Device Classification Name |
prosthesis, penile
|
510(k) Number |
K834347 |
Device Name |
FLEXI-FLATE PENILE IMPLANT |
Applicant |
SURGITEK |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SURGITEK |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.3630
|
Classification Product Code |
|
Date Received | 12/13/1983 |
Decision Date | 04/02/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|