JOHNSON AND JOHNSON POWER SYSTEM

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

JOHNSON & JOHNSON ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Johnson And Johnson Power System.

Pre-market Notification Details

Device IDK913629
510k NumberK913629
Device Name:JOHNSON AND JOHNSON POWER SYSTEM
ClassificationInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Applicant JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
ContactMarsha J Stone
CorrespondentMarsha J Stone
JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
Product CodeHSZ  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-15
Decision Date1991-11-13

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