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

HEWSON LIGAMENT BUTTON

K Number: K792004 · Decision Nov 5, 1979
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
19
Applicant Total
48
Review Days
33

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Basic Information

Device Name
HEWSON LIGAMENT BUTTON
K Number
K792004
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4930
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Richard'S Medical Equip., Inc.
Date Received
October 3, 1979
Decision Date
November 5, 1979
Product Code
KGS
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
KGS Retention Device, Suture

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Other Clearances by Richard'S Medical Equip., Inc.

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K823726 SPECTRON CONVERSION ENDOPROSTHESIS CUP
K823724 SPECTRON NECK REPLACEMENT PROSTHESIS
K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
K830154 COLLES FRACTURE FRAME
K823725 SPECTRON PROTRUSIO CUP
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