Device Classification Name |
Prosthesis, Laryngeal (Taub)
|
510(k) Number |
K945287 |
Device Name |
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE |
Applicant |
HELIX MEDICAL, INC. |
1110 MARK AVE. |
CARPINTERIA,
CA
93013
|
|
Applicant Contact |
STEPHEN W LAGUETTE |
Correspondent |
HELIX MEDICAL, INC. |
1110 MARK AVE. |
CARPINTERIA,
CA
93013
|
|
Correspondent Contact |
STEPHEN W LAGUETTE |
Regulation Number | 874.3730
|
Classification Product Code |
|
Date Received | 10/31/1994 |
Decision Date | 12/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|