Device Classification Name |
Elastomer, Silicone Block
|
510(k) Number |
K945552 |
Device Name |
DURALASTIC SHEETING |
Applicant |
APPLIED BIOMATERIAL TECHNOLOGIES |
9576 RIDGETOP BLVD. |
SILVERDALE,
WA
98383
|
|
Applicant Contact |
GERALD HANSON |
Correspondent |
APPLIED BIOMATERIAL TECHNOLOGIES |
9576 RIDGETOP BLVD. |
SILVERDALE,
WA
98383
|
|
Correspondent Contact |
GERALD HANSON |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 11/10/1994 |
Decision Date | 01/31/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|