The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Co2 Insufflation Tubing.
| Device ID | K922038 |
| 510k Number | K922038 |
| Device Name: | CO2 INSUFFLATION TUBING |
| Classification | Insufflator, Laparoscopic |
| Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Contact | Don W Haar |
| Correspondent | Don W Haar SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-01 |
| Decision Date | 1992-10-13 |