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

RICHARDS ACETABULAR BRUSH

K Number: K813093 · Decision Nov 20, 1981
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
8
Applicant Total
48
Review Days
18

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Basic Information

Device Name
RICHARDS ACETABULAR BRUSH
K Number
K813093
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Richard'S Medical Equip., Inc.
Date Received
November 2, 1981
Decision Date
November 20, 1981
Product Code
HTR
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
HTR Rasp

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

K Number Device Name
K830793 PATIENT GUIDED ELBOW & SHOULDER EXERC
K823837 RMC TOTAL KNEE SYSTEM
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
Search all 48 clearances from Richard'S Medical Equip., Inc. →