Device Classification Name |
Insufflator, Hysteroscopic
|
510(k) Number |
K970078 |
Device Name |
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM |
Applicant |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CRANSTON,
RI
02920
|
|
Applicant Contact |
ROBIN M DRAGO |
Correspondent |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CRANSTON,
RI
02920
|
|
Correspondent Contact |
ROBIN M DRAGO |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 01/09/1997 |
Decision Date | 12/11/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|