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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 K871169
Device Name LUBRICATING JELLY
Applicant
H & P Industries, Inc.
9640 S 60th St.
Franklin,  WI  53132
Applicant Contact KISHOR DESAI
Correspondent
H & P Industries, Inc.
9640 S 60th St.
Franklin,  WI  53132
Correspondent Contact KISHOR DESAI
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received03/24/1987
Decision Date 04/01/1987
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
Recalls CDRH Recalls
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