Device Classification Name |
n95 respirator with antimicrobial/antiviral agent
|
510(k) Number |
K090414 |
Device Name |
SPECTRASHIELD 9500 SURGICAL MASK |
Applicant |
NEXERA MEDICAL, INC |
1556 EAST COMMERCIAL BLVD. |
oakland park,
FL
33334 -5752
|
|
Applicant Contact |
paul sallarulo |
Correspondent |
NEXERA MEDICAL, INC |
1556 EAST COMMERCIAL BLVD. |
oakland park,
FL
33334 -5752
|
|
Correspondent Contact |
paul sallarulo |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 02/18/2009 |
Decision Date | 02/24/2011 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|