Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K130736 |
Device Name |
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS |
Applicant |
HELIX MEDICAL, LLC |
1110 MARK AVE. |
CARPINTERIA,
CA
93013
|
|
Applicant Contact |
THOMAS M VASSALLO |
Correspondent |
HELIX MEDICAL, LLC |
1110 MARK AVE. |
CARPINTERIA,
CA
93013
|
|
Correspondent Contact |
THOMAS M VASSALLO |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 03/18/2013 |
Decision Date | 12/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|