The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Hope Nebulizer.
| Device ID | K980407 |
| 510k Number | K980407 |
| Device Name: | HOPE NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
| Contact | Stephen W Briggs Iii |
| Correspondent | Stephen W Briggs Iii B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-03 |
| Decision Date | 1998-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008733024 | K980407 | 000 |
| 00850008733000 | K980407 | 000 |