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

DRILL, CORDLESS SURGICAL

K Number: K790063 · Decision Feb 5, 1979
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
48
Review Days
21

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Basic Information

Device Name
DRILL, CORDLESS SURGICAL
K Number
K790063
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4820
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Richard'S Medical Equip., Inc.
Date Received
January 15, 1979
Decision Date
February 5, 1979
Product Code
KIJ
Advisory Committee
General, Plastic Surgery
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
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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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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