Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K930696 |
Device Name |
SURE-FLO INSUFFLATION TUBING |
Applicant |
O.R. RESOURCES, INC. |
P.O. BOX 6563 |
ANNAPOLIS,
MD
21401
|
|
Applicant Contact |
STEVEN LINDSEY |
Correspondent |
O.R. RESOURCES, INC. |
P.O. BOX 6563 |
ANNAPOLIS,
MD
21401
|
|
Correspondent Contact |
STEVEN LINDSEY |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 02/10/1993 |
Decision Date | 04/19/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|