The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Tap Anti-snoring Device.
Device ID | K962516 |
510k Number | K962516 |
Device Name: | TAP ANTI-SNORING DEVICE |
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 | 1996-06-27 |
Decision Date | 1996-09-10 |
Summary: | summary |