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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 K910084
Device Name SURGICAL DRAPE
Applicant
Biocor Medical, Inc.
1008 Ncnb Center
102 N. College
Tyler,  TX  75702
Applicant Contact MICKEY FOWLER
Correspondent
Biocor Medical, Inc.
1008 Ncnb Center
102 N. College
Tyler,  TX  75702
Correspondent Contact MICKEY FOWLER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/08/1991
Decision Date 03/19/1991
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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