Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K012008
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K012008
Device Name
Sleeve, Limb, Compressible
Applicant
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN, NJ 07724-3327 US
Other 510(k) Applications for this Company
Contact
AUDREY WITKO
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2001
Decision Date
09/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact