The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for C.p.a.p. Valve And C.p.p.a. Kit.
| Device ID | K895360 |
| 510k Number | K895360 |
| Device Name: | C.P.A.P. VALVE AND C.P.P.A. KIT |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Chamberlain Jr |
| Correspondent | Chamberlain Jr BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-28 |
| Decision Date | 1989-11-15 |