Device Classification Name |
Tenaculum, Uterine
|
510(k) Number |
K073182 |
Device Name |
GYN DISPOSABLES TENACULUM 356T |
Applicant |
GYN-DISPOSABLES, INC. |
2671 APPLING ROAD |
MEMPHIS,
TN
38133 -5001
|
|
Applicant Contact |
JAMES K PATTERSON |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/13/2007 |
Decision Date | 11/28/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|