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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 K893814
Device Name SURGICAL INSTRUMENT KIT, DISPOSABLE
Applicant
Bioseal
350 N. Palm
Brea,  CA  92621
Applicant Contact WILLIAM L RUNION
Correspondent
Bioseal
350 N. Palm
Brea,  CA  92621
Correspondent Contact WILLIAM L RUNION
Regulation Number878.4370
Classification Product Code
LRO  
Date Received05/23/1989
Decision Date 08/10/1989
Decision Substantially Equivalent (SESE)
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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