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

MINOR SURGERY LIGHT

K Number: K810207 · Decision Feb 13, 1981
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
32
Review Days
18

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Basic Information

Device Name
MINOR SURGERY LIGHT
K Number
K810207
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4580
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Cavitron Corp.
Date Received
January 26, 1981
Decision Date
February 13, 1981
Product Code
GBC
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
GBC Lamp, Surgical, Incandescent

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K801877 SLIT LAMP ATTACHMENT
K800869 MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA
K800722 AUTO-FIELD D AUTOMATED VISUAL DETECTOR
K791585 MODEL G-61 ULTRASONIC DENTAL UNIT
K791277 MODEL 6500 EXTRACTION IRRIGATION SYS
K782054 LASER, CO2 SURGICAL
K782065 LASER, PHOTOCOAGULATION
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