Device Classification Name |
prosthesis, breast, external, used with adhesive
|
510(k) Number |
K990458 |
Device Name |
STRAUMANN EXTRAORAL IMPLANT SYSTEM |
Applicant |
STRAUMANN USA |
RESERVOIR PLACE, |
1601 TRAPELO ROAD |
WALTHAM,
MA
02154
|
|
Applicant Contact |
LINDA JALBERT |
Correspondent |
STRAUMANN USA |
RESERVOIR PLACE, |
1601 TRAPELO ROAD |
WALTHAM,
MA
02154
|
|
Correspondent Contact |
LINDA JALBERT |
Regulation Number | 878.3800
|
Classification Product Code |
|
Date Received | 02/12/1999 |
Decision Date | 04/16/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|