CONCEPT POWER SYSTEM

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

CONCEPT, INC.

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

Pre-market Notification Details

Device IDK881954
510k NumberK881954
Device Name:CONCEPT POWER SYSTEM
ClassificationInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Applicant CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
ContactMartha C Miller
CorrespondentMartha C Miller
CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
Product CodeHSZ  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-10
Decision Date1988-11-09

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