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

HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE

K Number: K890972 · Decision Mar 22, 1989
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
28
Review Days
23

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Basic Information

Device Name
HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE
K Number
K890972
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Instrument Makar, Inc.
Date Received
February 27, 1989
Decision Date
March 22, 1989
Product Code
JOS
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
JOS Electrode, Electrosurgical

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