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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K922423
Device Name ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM.
Applicant
Access Surgical Intl., Inc.
420 Rte. 206 N., Suite 200
Bedminster,  NJ  07921
Applicant Contact WAYNE R KNUPP
Correspondent
Access Surgical Intl., Inc.
420 Rte. 206 N., Suite 200
Bedminster,  NJ  07921
Correspondent Contact WAYNE R KNUPP
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/21/1992
Decision Date 11/18/1992
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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