Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K950219 |
Device Name |
ENDOLAP INSUFFLATOR TUBING SET |
Applicant |
ENDOLAP, INC. |
3012 MERCY DR. |
ORLANDO,
FL
32808
|
|
Applicant Contact |
L.A. TONY GILSTRAP |
Correspondent |
ENDOLAP, INC. |
3012 MERCY DR. |
ORLANDO,
FL
32808
|
|
Correspondent Contact |
L.A. TONY GILSTRAP |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 01/19/1995 |
Decision Date | 03/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|