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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angioscope
510(k) Number K911090
Device Name OMEGA ANGIOSCOPES (OMEGASCOPES)
Applicant
Omega Universal Technologies, Ltd.
28 Marigold Ln.
Marlboro,  NJ  07746
Applicant Contact MARTIN S KNOPF
Correspondent
Omega Universal Technologies, Ltd.
28 Marigold Ln.
Marlboro,  NJ  07746
Correspondent Contact MARTIN S KNOPF
Regulation Number876.1500
Classification Product Code
LYK  
Date Received03/11/1991
Decision Date 07/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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