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

AUTO SUTURE R CLIP INSTRUMENT

K Number: K771113 · Decision Sep 30, 1977
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
41
Applicant Total
218
Review Days
101

Basic Information

Device Name
AUTO SUTURE R CLIP INSTRUMENT
K Number
K771113
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4740
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Date Received
June 21, 1977
Decision Date
September 30, 1977
Product Code
GAG
Advisory Committee
General Hospital
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
GAG Stapler, Surgical

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