The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Rectal Tube.
| Device ID | K921852 |
| 510k Number | K921852 |
| Device Name: | 4 SURE TM RECTAL TUBE |
| Classification | Binder, Elastic |
| Applicant | BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
| Contact | Randal Green |
| Correspondent | Randal Green BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
| Product Code | KMO |
| CFR Regulation Number | 880.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1993-10-08 |