The following data is part of a premarket notification filed by Jerry Mccarty with the FDA for Hand-e-breath.
| Device ID | K921339 |
| 510k Number | K921339 |
| Device Name: | HAND-E-BREATH |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | JERRY MCCARTY 8305 WINDWAY DR. San Antonio, TX 78239 |
| Contact | Jerry Mccarty |
| Correspondent | Jerry Mccarty JERRY MCCARTY 8305 WINDWAY DR. San Antonio, TX 78239 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-18 |
| Decision Date | 1992-10-01 |