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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K924055
Device Name N-PAC
Applicant
National Healthcare Linen Service
605 Packard Ct.
Safety Harbor,  FL  34695
Applicant Contact LARRY PATTERSON
Correspondent
National Healthcare Linen Service
605 Packard Ct.
Safety Harbor,  FL  34695
Correspondent Contact LARRY PATTERSON
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Code
FYC  
Date Received08/12/1992
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit (SESK)
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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