The following data is part of a premarket notification filed by Respire Medical Holding with the FDA for Respire Pink Series-herbst-ef.
Device ID | K150572 |
510k Number | K150572 |
Device Name: | Respire Pink Series-Herbst-EF |
Classification | Device, Anti-snoring |
Applicant | Respire Medical Holding 18 Bridge St Suite 4J Brooklyn, NY 11201 |
Contact | David Walton |
Correspondent | Stephen W Inglese Quality Solutions And Support, LLC PO BOX 8271 Holland, MI 49422 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-06 |
Decision Date | 2015-08-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851861007154 | K150572 | 000 |
00851861007062 | K150572 | 000 |
00851861007055 | K150572 | 000 |