Device Classification Name |
Source, Carrier, Fiberoptic Light
|
510(k) Number |
K934911 |
Device Name |
SAPHIRE PLUS SURGICAL MIRROR |
Applicant |
SAN DIEGO SWISS MACHINING, INC. |
11222 WALABY COURT |
SAN DIEGO,
CA
92128
|
|
Applicant Contact |
ALAN DONALD |
Correspondent |
SAN DIEGO SWISS MACHINING, INC. |
11222 WALABY COURT |
SAN DIEGO,
CA
92128
|
|
Correspondent Contact |
ALAN DONALD |
Regulation Number | 874.4350
|
Classification Product Code |
|
Date Received | 10/14/1993 |
Decision Date | 06/21/1994 |
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
|
|
|