Device Classification Name |
spacer, direct patient interface
|
510(k) Number |
K091862 |
Device Name |
NESSI SPACER |
Applicant |
PHARMACARIBE |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
PHARMACARIBE |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 06/23/2009 |
Decision Date | 11/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|