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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K872128
Device Name K-GEL
Applicant
Taro Pharmaceuticals, Inc.
305 Supertest Rd.
Downsview, Ont.,  CA
Applicant Contact KOEHLER
Correspondent
Taro Pharmaceuticals, Inc.
305 Supertest Rd.
Downsview, Ont.,  CA
Correspondent Contact KOEHLER
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received06/02/1987
Decision Date 06/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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