The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Tap.
| Device ID | K964516 |
| 510k Number | K964516 |
| Device Name: | TAP |
| Classification | Device, Anti-snoring |
| Applicant | NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Chris Hadland |
| Correspondent | Chris Hadland NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-05 |
| Decision Date | 1997-01-24 |
| Summary: | summary |