The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Taut-insufflation Needle.
| Device ID | K003703 |
| 510k Number | K003703 |
| Device Name: | TAUT-INSUFFLATION NEEDLE |
| Classification | Insufflator, Laparoscopic |
| Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Contact | Ronald Kenseth |
| Correspondent | Ronald Kenseth TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-01 |
| Decision Date | 2001-02-22 |