The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Pantino Pro Positiner.
Device ID | K102521 |
510k Number | K102521 |
Device Name: | PANTINO PRO POSITINER |
Classification | Device, Anti-snoring |
Applicant | SOMNOMED INC. 3537 TEASLEY LANE Denton, TX 76210 |
Contact | Bradley Southworth |
Correspondent | Bradley Southworth SOMNOMED INC. 3537 TEASLEY LANE Denton, TX 76210 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-02 |
Decision Date | 2011-03-28 |
Summary: | summary |