The following data is part of a premarket notification filed by Sun Medical, Inc. with the FDA for Disposable, Filtered Insufflation Tubing, 92-900.
| Device ID | K921963 |
| 510k Number | K921963 |
| Device Name: | DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 |
| Classification | Insufflator, Laparoscopic |
| Applicant | SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006 |
| Contact | David Lee |
| Correspondent | David Lee SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-27 |
| Decision Date | 1992-09-11 |