The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Insufflation Tubing.
| Device ID | K925691 |
| 510k Number | K925691 |
| Device Name: | INSUFFLATION TUBING |
| Classification | Insufflator, Laparoscopic |
| Applicant | MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Contact | Thomas P Clement |
| Correspondent | Thomas P Clement MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1993-09-23 |