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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 K933699
Device Name GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS
Applicant
Geister Medizin Technik GmbH
203 Main St.
Suite A-166
Flemington,  NJ  08822
Applicant Contact LYNETTE L HOWARD
Correspondent
Geister Medizin Technik GmbH
203 Main St.
Suite A-166
Flemington,  NJ  08822
Correspondent Contact LYNETTE L HOWARD
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/29/1993
Decision Date 01/27/1994
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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