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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K840344
Device Name PDI PREPMASTER WET PACK MINOR PROCEDURE
Applicant
Nice-Pak Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Nice-Pak Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/06/1984
Decision Date 03/26/1984
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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