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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 K930666
Device Name REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY
Applicant
Snowden-Pencer
2058 Kilman Dr.
Tucker,  GA  30084
Applicant Contact NORMAN M BLACK
Correspondent
Snowden-Pencer
2058 Kilman Dr.
Tucker,  GA  30084
Correspondent Contact NORMAN M BLACK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/09/1993
Decision Date 05/19/1994
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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