Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K921963 |
Device Name |
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 |
Applicant |
SUN MEDICAL, INC. |
1170 CORPORATE DRIVE WEST |
SUITE 100 |
ARLINGTON,
TX
76006
|
|
Applicant Contact |
DAVID LEE |
Correspondent |
SUN MEDICAL, INC. |
1170 CORPORATE DRIVE WEST |
SUITE 100 |
ARLINGTON,
TX
76006
|
|
Correspondent Contact |
DAVID LEE |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 04/27/1992 |
Decision Date | 09/11/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|