The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Heated Insufflator Tube Set.
| Device ID | K003792 |
| 510k Number | K003792 |
| Device Name: | STRYKER HEATED INSUFFLATOR TUBE SET |
| Classification | Insufflator, Laparoscopic |
| Applicant | STRYKER CORP. 2590 WALSH AVE. Santa Clara, CA 95051 |
| Contact | Michael Baycura |
| Correspondent | Michael Baycura STRYKER CORP. 2590 WALSH AVE. Santa Clara, CA 95051 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-02-21 |