The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Insufflator Tubing Kit.
| Device ID | K922197 |
| 510k Number | K922197 |
| Device Name: | INSUFFLATOR TUBING KIT |
| Classification | Insufflator, Hysteroscopic |
| 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 | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-11 |
| Decision Date | 1993-09-24 |