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FDA REQUESTS INFORMATION REGARDING DSD-91 FROM MEDIVATORS

 FDA REQUESTS INFORMATION REGARDING DSD-91 FROM MEDIVATORS
 CANNON FALLS, Minn., March 31 /PRNewswire/ -- MediVators, Inc. (NASDAQ: MVAT) received a request on March 27, 1992, for additional information to determine if the DSD-91, the company's dual scope disinfector, is substantially equivalent medical device with regard to its safety and effectiveness. In September 1991, MediVators filed a premarket notification on Form 510(k) with the Food and Drug Administration (FDA). In November 1991, the company received a request for information from the FDA and in December 1991 the company responded to that request. The company intends to respond to the latest request for additional information within 30 days.
 The company may not market the DSD-91 in the United States until it has received FDA notification that their requirements have been fulfilled. Due to regulatory delay, the company is accelerating its international manufacturing activities which will consist of final assembly and test of the DSD-91. The company is currently negotiating contract manufacturing agreements with its distributors in the United Kingdom, France and Canada.
 MediVators, Inc. designs, manufactures and markets endoscope disinfection equipment and accessories and a patented sharps disposal system.
 -0- 3/31/92
 /CONTACT: Curtis D. Luebke or Donald L. Sturtevant, 507-263-4721/
 (MVAT) CO: MediVators, Inc. ST: Minnesota IN: MTC SU:


AL -- MN005 -- 3362 03/31/92 11:09 EST
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Copyright 1992 Gale, Cengage Learning. All rights reserved.

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Publication:PR Newswire
Date:Mar 31, 1992
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