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

WRENCH

K Number: K791073 · Decision Jun 20, 1979
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
5
Applicant Total
1
Review Days
8

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Basic Information

Device Name
WRENCH
K Number
K791073
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
888.4540
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Truth, Inc.
Date Received
June 12, 1979
Decision Date
June 20, 1979
Product Code
HXC
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HXC Wrench

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