Device Classification Name |
arthroscope
|
510(k) Number |
K121261 |
Device Name |
ASAP MUITISCOPE |
Applicant |
ASAP ENDOSCOPIC PRODUCTS GMBH |
AMSTEL 320-I |
AMSTERDAM,
NL
1017AP
|
|
Applicant Contact |
ANGELIKA SCHERP |
Correspondent |
ASAP ENDOSCOPIC PRODUCTS GMBH |
AMSTEL 320-I |
AMSTERDAM,
NL
1017AP
|
|
Correspondent Contact |
ANGELIKA SCHERP |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 04/26/2012 |
Decision Date | 01/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|