The following data is part of a premarket notification filed by Invamed, Inc. with the FDA for Invamed Reusable Laparoscopic Trocar System.
| Device ID | K936011 |
| 510k Number | K936011 |
| Device Name: | INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | INVAMED, INC. 11202 FOREST RAIN San Antonio, TX 78233 |
| Contact | Phil Wolf |
| Correspondent | Phil Wolf INVAMED, INC. 11202 FOREST RAIN San Antonio, TX 78233 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-16 |
| Decision Date | 1994-09-21 |