Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K913979 |
Device Name |
ENDO I/A Y SET |
Applicant |
SNOWDEN-PENCER |
2058 KILMAN DR. |
TUCKER,
GA
30084
|
|
Applicant Contact |
NORMAN M BLACK |
Correspondent |
SNOWDEN-PENCER |
2058 KILMAN DR. |
TUCKER,
GA
30084
|
|
Correspondent Contact |
NORMAN M BLACK |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 09/06/1991 |
Decision Date | 11/27/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|