Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K981800 |
Device Name |
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 |
Applicant |
EQUAL DIAGNOSTICS, INC. |
115 SUMMIT DR. |
EXTON,
PA
19341
|
|
Applicant Contact |
BRENDA Y KAN |
Correspondent |
EQUAL DIAGNOSTICS, INC. |
115 SUMMIT DR. |
EXTON,
PA
19341
|
|
Correspondent Contact |
BRENDA Y KAN |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/21/1998 |
Decision Date | 07/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Toxicology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|