Device Classification Name |
Elastomer, Silicone Block
|
510(k) Number |
K042380 |
Device Name |
SILICONE BLOCK |
Applicant |
NATIONAL MEDICAL DEVICES, INC. |
8500 WILSHIRE BLVD. |
SUITE 707 |
BEVERLY HILLS,
CA
90211
|
|
Applicant Contact |
JAMES ELIST |
Correspondent |
NATIONAL MEDICAL DEVICES, INC. |
8500 WILSHIRE BLVD. |
SUITE 707 |
BEVERLY HILLS,
CA
90211
|
|
Correspondent Contact |
JAMES ELIST |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 09/01/2004 |
Decision Date | 10/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|