The following data is part of a premarket notification filed by Tahoe Surgical Instruments P.r., Inc. with the FDA for Tsi Willen-reich Needle.
| Device ID | K950726 |
| 510k Number | K950726 |
| Device Name: | TSI WILLEN-REICH NEEDLE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TAHOE SURGICAL INSTRUMENTS P.R., INC. 954 PONCE DE LEON AVE. San Juan, PR 00907 |
| Contact | Jon A Stevens |
| Correspondent | Jon A Stevens TAHOE SURGICAL INSTRUMENTS P.R., INC. 954 PONCE DE LEON AVE. San Juan, PR 00907 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-16 |
| Decision Date | 1995-04-18 |