The following data is part of a premarket notification filed by Surgical Instrument Repair Service Co. with the FDA for Intra-articular C02 Insufflator.
| Device ID | K823499 |
| 510k Number | K823499 |
| Device Name: | INTRA-ARTICULAR C02 INSUFFLATOR |
| Classification | Arthroscope |
| Applicant | SURGICAL INSTRUMENT REPAIR SERVICE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-24 |
| Decision Date | 1983-01-28 |