O.R.C. ADAPTER

Laparoscope, General & Plastic Surgery

O.R. CONCEPTS, INC.

The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for O.r.c. Adapter.

Pre-market Notification Details

Device IDK922405
510k NumberK922405
Device Name:O.R.C. ADAPTER
ClassificationLaparoscope, General & Plastic Surgery
Applicant O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
ContactJohn Mayall
CorrespondentJohn Mayall
O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-21
Decision Date1992-08-14

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