Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K012658 |
Device Name |
REPROCESSED COMPRESSION LIMB SLEEVES |
Applicant |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
3636 E COLUMBINE DR. |
PHOENIX,
AZ
85032 -5655
|
|
Applicant Contact |
ROBERT S MCQUATE |
Correspondent |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
3636 E COLUMBINE DR. |
PHOENIX,
AZ
85032 -5655
|
|
Correspondent Contact |
ROBERT S MCQUATE |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 05/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|