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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 K974768
Device Name PDI STERILE LUBRICATING JELLY
Applicant
Nice-Pak Products, Inc.
Two Nice-Pak Park
Orangeburg,  NY  10962
Applicant Contact GARY VANCE
Correspondent
Nice-Pak Products, Inc.
Two Nice-Pak Park
Orangeburg,  NY  10962
Correspondent Contact GARY VANCE
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received12/22/1997
Decision Date 01/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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