The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4sure Uro-link Urological Procedure Trays.
| Device ID | K933109 |
| 510k Number | K933109 |
| Device Name: | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS |
| Classification | Catheter, Urological |
| Applicant | BOSTON PACIFIC MEDICAL, INC. 451 D ST. SUITE 811 Boston, MA 02210 |
| Contact | Howard Hutchinson |
| Correspondent | Howard Hutchinson BOSTON PACIFIC MEDICAL, INC. 451 D ST. SUITE 811 Boston, MA 02210 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-25 |
| Decision Date | 1994-03-28 |