INTERMEDICS ORTHOPEDICS DRILL BITS

Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Orthopedics Drill Bits.

Pre-market Notification Details

Device IDK931734
510k NumberK931734
Device Name:INTERMEDICS ORTHOPEDICS DRILL BITS
ClassificationInstrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactJoann Ringer
CorrespondentJoann Ringer
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeHWE  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-07
Decision Date1994-02-22

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