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

HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES

K Number: K873742 · Decision Oct 1, 1987
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
19
Review Days
15

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Basic Information

Device Name
HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES
K Number
K873742
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.3720
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Hood Laboratories
Date Received
September 16, 1987
Decision Date
October 1, 1987
Product Code
NWA
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
NWA Prosthesis, Tracheal, Preformed/Molded

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K897049 GIBSON ENDOLYMPHATIC SHUNT
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K893866 HOOD PEDIATRIC TRACHEOSTOMY TUBE
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