The following data is part of a premarket notification filed by Vascular Control Systems, Inc with the FDA for Burbank Tenaculum.
| Device ID | K060573 |
| 510k Number | K060573 |
| Device Name: | BURBANK TENACULUM |
| Classification | Tenaculum, Uterine |
| Applicant | VASCULAR CONTROL SYSTEMS, INC 32236-F PASEO ADELANTO San Juan Capistrano, CA 92675 |
| Contact | Kathleen Roberts |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-06 |
| Decision Date | 2006-04-21 |
| Summary: | summary |