The following data is part of a premarket notification filed by Airways Development, Llc with the FDA for Waterpap Valve.
| Device ID | K110713 |
| 510k Number | K110713 |
| Device Name: | WATERPAP VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | AIRWAYS DEVELOPMENT, LLC P.O. BOX 558 Cedar Knolls, NJ 07927 |
| Contact | Richard J Larkin |
| Correspondent | Richard J Larkin AIRWAYS DEVELOPMENT, LLC P.O. BOX 558 Cedar Knolls, NJ 07927 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-15 |
| Decision Date | 2011-09-12 |
| Summary: | summary |