INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)

Arthroscope

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Intravision(tm) Arthroscope System (add'l Appli.).

Pre-market Notification Details

Device IDK892376
510k NumberK892376
Device Name:INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
ClassificationArthroscope
Applicant CONCEPT, INC. 11311 CONCEPT BLVD. Largo,  FL  34643
ContactMartha C Miller
CorrespondentMartha C Miller
CONCEPT, INC. 11311 CONCEPT BLVD. Largo,  FL  34643
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-05
Decision Date1989-08-01

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