The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Anesthesia Extension Set.
| Device ID | K924995 |
| 510k Number | K924995 |
| Device Name: | 4 SURE TM ANESTHESIA EXTENSION SET |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | BOSTON PACIFIC MEDICAL, INC. 451 D ST. SUITE 811 Boston, MA 02210 |
| Contact | Richard A Derosa |
| Correspondent | Richard A Derosa BOSTON PACIFIC MEDICAL, INC. 451 D ST. SUITE 811 Boston, MA 02210 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-01 |
| Decision Date | 1992-12-30 |