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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
510(k) Number K936210
Device Name NPAC
Applicant
NATIONAL HEALTHCARE LINEN SERVICE
1776 11TH AVENUE, NORTH
ST. PETERSBURG,  FL  33713
Applicant Contact JOE CARRENS
Correspondent
NATIONAL HEALTHCARE LINEN SERVICE
1776 11TH AVENUE, NORTH
ST. PETERSBURG,  FL  33713
Correspondent Contact JOE CARRENS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/29/1993
Decision Date 02/03/1994
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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