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

TECNOL BUCKS TRACTION W/HEEL PROTECTOR

K Number: K884132 · Decision Oct 11, 1988
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
10
Applicant Total
2
Review Days
11

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Basic Information

Device Name
TECNOL BUCKS TRACTION W/HEEL PROTECTOR
K Number
K884132
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
888.5890
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Technol, Inc.
Date Received
September 30, 1988
Decision Date
October 11, 1988
Product Code
KQZ
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
KQZ Component, Traction, Non-Invasive

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K Number Device Name
K861528 TECNOL PERSONAL SHOE COVER