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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K902293
Device Name ANGIOGRAPHY DRAPE PACK
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
LRO  
Date Received05/22/1990
Decision Date 07/19/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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