The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for O.r.c. Adapter.
Device ID | K922405 |
510k Number | K922405 |
Device Name: | O.R.C. ADAPTER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
Contact | John Mayall |
Correspondent | John Mayall O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-21 |
Decision Date | 1992-08-14 |