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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 K131617
Device Name COLONGLIDE(R) LUBRICANT
Applicant
PEDIATRIC PHARMACEUTICALS, INC.
2137 ROUTE 35
HOLMDEL,  NJ  07733
Applicant Contact ROBERT M HARRIS
Correspondent
PEDIATRIC PHARMACEUTICALS, INC.
2137 ROUTE 35
HOLMDEL,  NJ  07733
Correspondent Contact ROBERT M HARRIS
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received06/03/2013
Decision Date 10/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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