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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K840343
Device Name PDI PREPMASTER WET PACK VAGINAL-X21477
Applicant
Nice-Pak Products, Inc.
150n Macquesten Pkwy.
Mt. Vernon,  NY  10550
Applicant Contact JOSEPH J GENOVESE
Correspondent
Nice-Pak Products, Inc.
150n Macquesten Pkwy.
Mt. Vernon,  NY  10550
Correspondent Contact JOSEPH J GENOVESE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/06/1984
Decision Date 03/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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