Device Classification Name |
Prosthesis, Laryngeal (Taub)
|
510(k) Number |
K930105 |
Device Name |
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. |
Applicant |
HELIX MEDICAL, INC. |
210 SANTA BARBERA ST. |
SANTA BARBERA,
CA
93101
|
|
Applicant Contact |
CHRISTINE EMANUEL |
Correspondent |
HELIX MEDICAL, INC. |
210 SANTA BARBERA ST. |
SANTA BARBERA,
CA
93101
|
|
Correspondent Contact |
CHRISTINE EMANUEL |
Regulation Number | 874.3730
|
Classification Product Code |
|
Date Received | 01/11/1993 |
Decision Date | 05/17/1993 |
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
|
|
|