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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 K922425
Device Name ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM
Applicant
Access Surgical Intl., Inc.
420 Rte. 206 N., Suite 200
Bedminster,  NJ  07921
Applicant Contact KNUPP
Correspondent
Access Surgical Intl., Inc.
420 Rte. 206 N., Suite 200
Bedminster,  NJ  07921
Correspondent Contact KNUPP
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/21/1992
Decision Date 11/17/1992
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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