Device Classification Name |
device, anti-snoring
|
510(k) Number |
K150572 |
FOIA Releasable 510(k) |
K150572
|
Device Name |
Respire Pink Series-Herbst-EF |
Applicant |
Respire Medical Holding |
18 Bridge St Suite 4J |
Brooklyn,
NY
11201
|
|
Applicant Contact |
David Walton |
Correspondent |
Quality Solutions and Support, LLC |
PO BOX 8271 |
Holland,
MI
49422
|
|
Correspondent Contact |
Stephen W Inglese |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 03/06/2015 |
Decision Date | 08/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|