The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Enteral Feeding Bag.
| Device ID | K922402 |
| 510k Number | K922402 |
| Device Name: | 4 SURE TM ENTERAL FEEDING BAG |
| Classification | Tube, Feeding |
| 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 | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1994-03-25 |