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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 K951431
Device Name AQUAGEL LUBRICATING JELLY
Applicant
Depuy Healthcare
93 Birch Hill Rd.
Stow,  MA  01775
Applicant Contact JAMES M PARKER
Correspondent
Depuy Healthcare
93 Birch Hill Rd.
Stow,  MA  01775
Correspondent Contact JAMES M PARKER
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received03/27/1995
Decision Date 07/21/1995
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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