The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Enema Bag Set.
| Device ID | K922398 |
| 510k Number | K922398 |
| Device Name: | 4 SURE TM ENEMA BAG SET |
| Classification | Enema Kit |
| 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 | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1993-06-17 |