Device Classification Name |
dilator, nasal
|
510(k) Number |
K962698 |
Device Name |
ACUTEK'S CLEARPASAGE |
Applicant |
ACUTEK ADHESIVE SPECIALTIES, INC. |
540 NORTH OAK ST. |
INGLEWOOD,
CA
90302
|
|
Applicant Contact |
MARCIA FAJARDO |
Correspondent |
ACUTEK ADHESIVE SPECIALTIES, INC. |
540 NORTH OAK ST. |
INGLEWOOD,
CA
90302
|
|
Correspondent Contact |
MARCIA FAJARDO |
Regulation Number | 874.3900
|
Classification Product Code |
|
Date Received | 06/17/1996 |
Decision Date | 09/09/1996 |
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
|
|
|