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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Jelly, Lubricating, For Transurethral Surgical Instrument
510(k) Number K912132
Device Name OPERAND LUBRICATING JELLY
Applicant
General Medical Co.
P.O. Box 237
Prichard Industrial Park
Prichard,  WV  25555
Applicant Contact RICHARD J MARSHALL
Correspondent
General Medical Co.
P.O. Box 237
Prichard Industrial Park
Prichard,  WV  25555
Correspondent Contact RICHARD J MARSHALL
Regulation Number876.1500
Classification Product Code
FHX  
Date Received05/14/1991
Decision Date 08/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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