Device Classification Name |
source, chemiluminescent light
|
510(k) Number |
K963391 |
Device Name |
SPECULITE |
Applicant |
TRYLON CORP. |
23268 ATLANTIS WAY |
MONARCH BEACH,
CA
92629
|
|
Applicant Contact |
A. THOMAS DOYLE |
Correspondent |
TRYLON CORP. |
23268 ATLANTIS WAY |
MONARCH BEACH,
CA
92629
|
|
Correspondent Contact |
A. THOMAS DOYLE |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/28/1996 |
Decision Date | 12/12/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|