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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K923688
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 Number878.4370
Classification Product Code
KKX  
Date Received07/23/1992
Decision Date 01/27/1993
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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