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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 K850199
Device Name POLY-LINED TOWEL/DRAPE LINE
Applicant
EXCEL HEALTH CARE PRODUCTS
5001 HADLEY RD.
SOUTH PLAINFIELD,  NJ  07080
Applicant Contact DAVID CATLIN
Correspondent
EXCEL HEALTH CARE PRODUCTS
5001 HADLEY RD.
SOUTH PLAINFIELD,  NJ  07080
Correspondent Contact DAVID CATLIN
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/18/1985
Decision Date 02/21/1985
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
Recalls CDRH Recalls
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