Device Classification Name |
Speculum, Vaginal, Nonmetal
|
510(k) Number |
K070964 |
Device Name |
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM |
Applicant |
WELCH ALLYN, INC. |
4341 STATE STREET ROAD |
PO BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
CHRIS HORACEK |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE STREET ROAD |
PO BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
CHRIS HORACEK |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/05/2007 |
Decision Date | 05/18/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|