ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP

Arthroscope

ORTHOCONCEPT, INC.

The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Orthoconcept Arthroscopic Pump Orthopump.

Pre-market Notification Details

Device IDK872270
510k NumberK872270
Device Name:ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP
ClassificationArthroscope
Applicant ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia,  SC  29223
ContactJack Defranco
CorrespondentJack Defranco
ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia,  SC  29223
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-12
Decision Date1987-07-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.