Device Classification Name |
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K050355 |
Device Name |
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 |
Applicant |
TISSUE SCIENCE LABORATORIES, PLC |
1141 CLARK STREET, SUITE D |
COVINGTON,
GA
30014
|
|
Applicant Contact |
VICTORIA TAYLOR |
Correspondent |
TISSUE SCIENCE LABORATORIES, PLC |
1141 CLARK STREET, SUITE D |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
VICTORIA TAYLOR |
Regulation Number | 884.5980
|
Classification Product Code |
|
Date Received | 02/14/2005 |
Decision Date | 03/09/2005 |
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
|
|
|