FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

CONMED BEAMER SYSTEM C600

K Number: K081678 · Decision Jul 29, 2008
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
2
Review Days
42

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Basic Information

Device Name
CONMED BEAMER SYSTEM C600
K Number
K081678
Device Class
FDA class 2
Clearance Type
Abbreviated
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Kls Martin GmbH + Co. KG
Date Received
June 17, 2008
Decision Date
July 29, 2008
Product Code
GEI
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
Y

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

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K Number Device Name
K183526 Codman Electrosurgical Generator, Foot Pedal