The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel High Precision Vascular Punch(tm).
| Device ID | K890432 |
| 510k Number | K890432 |
| Device Name: | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-04-13 |