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

ANADIAS NASAL SAW BLADES

K Number: K854192 · Decision Nov 13, 1985
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
26
Applicant Total
2
Review Days
29

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Basic Information

Device Name
ANADIAS NASAL SAW BLADES
K Number
K854192
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4820
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Anadias, Inc.
Date Received
October 15, 1985
Decision Date
November 13, 1985
Product Code
GFA
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
GFA Blade, Saw, General & Plastic Surgery, Surgical

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Other Clearances by Anadias, Inc.

K Number Device Name
K871190 ANADIAS ZARA SYSTEM MALAR IMPLANTS