The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Nasal Oxygen Cannula.
| Device ID | K922397 |
| 510k Number | K922397 |
| Device Name: | 4 SURE TM NASAL OXYGEN CANNULA |
| Classification | Cannula, Nasal, Oxygen |
| 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 | CAT |
| CFR Regulation Number | 868.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1993-03-18 |