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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 K850960
Device Name NON-ABSORBENT DRAPES & ABSORBENT TOWELS
Applicant
Excel Health Care Products
5001 Hadley Rd.
S. Plainfield,  NJ  07080
Applicant Contact MICHAEL SHANNON
Correspondent
Excel Health Care Products
5001 Hadley Rd.
S. Plainfield,  NJ  07080
Correspondent Contact MICHAEL SHANNON
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/08/1985
Decision Date 03/15/1986
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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