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

AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT

K Number: K910942 · Decision Jun 11, 1991
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
19
Applicant Total
8
Review Days
97

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Basic Information

Device Name
AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT
K Number
K910942
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4580
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Mdt Biologic Co.
Date Received
March 6, 1991
Decision Date
June 11, 1991
Product Code
FSS
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
FSS Light, Surgical, Floor Standing

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Other Clearances by Mdt Biologic Co.

K Number Device Name
K954736 ACCESS (POWERCLAVE)
K954940 MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
K943654 HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
K911087 CASTLE WASHER/DISINFECTOR, MODEL 7550
K910777 MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER
K910778 STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
K910649 MDT/CASTLE 10/90 LOAD STATION