The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Colostomy Pouch.
| Device ID | K922401 |
| 510k Number | K922401 |
| Device Name: | 4 SURE TM COLOSTOMY POUCH |
| Classification | Pouch, Colostomy |
| Applicant | BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
| Contact | Randall Green |
| Correspondent | Randall Green BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
| Product Code | EZQ |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1992-06-10 |