The following data is part of a premarket notification filed by Henley Intl. with the FDA for Surgical Duct Clamp (vine).
| Device ID | K882169 |
| 510k Number | K882169 |
| Device Name: | SURGICAL DUCT CLAMP (VINE) |
| Classification | Clamp, Surgical, General & Plastic Surgery |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | GDJ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-24 |
| Decision Date | 1988-06-17 |