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

VALTRAC(R) INTRODUCER FORCEP

K Number: K922348 · Decision Jun 9, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
7
Review Days
21

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Basic Information

Device Name
VALTRAC(R) INTRODUCER FORCEP
K Number
K922348
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4580
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
American Cyanamid Co.
Date Received
May 19, 1992
Decision Date
June 9, 1992
Product Code
HJE
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
HJE Lamp, Fluorescein, Ac-Powered

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K900198 DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
K896946 COATED NOVAFIL, POLYBUTESTER, MESH
K823552 APPOSE SKIN STAPLER & REMOVER