FDA 510(k), K012651, HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
FDA 510(k), K012651, HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
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510(K) Number: K012651
Device Name: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
Manufacturer: GEOFF M FATZINGER
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: 08/13/2001
Date Received: 04/12/2002
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
Manufacturer: GEOFF M FATZINGER
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: 08/13/2001
Date Received: 04/12/2002
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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