FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

CHRISTOUDIAS SLIM TIP ELECTRODE INSERT

K Number: K992345 · Decision Sep 10, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
89

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Basic Information

Device Name
CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
K Number
K992345
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Innervision, Inc.
Date Received
June 13, 1999
Decision Date
September 10, 1999
Product Code
GEI
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

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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K991877 MACMED PAEDIATRIC INTRAMEDULLARY NAIL
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K940731 INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES
K940750 INNERVISION,INC. LAPAROSCOPIC ELECTRODES
K940718 INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS