FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

SKIN SCRUB KITS

K Number: K811855 · Decision Jul 31, 1981
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
5
Review Days
30

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Basic Information

Device Name
SKIN SCRUB KITS
K Number
K811855
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Oem Medical Div.
Date Received
July 1, 1981
Decision Date
July 31, 1981
Product Code
KDD
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
KDD Kit, Surgical Instrument, Disposable

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