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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: KXA
Date Received: 08/13/2001
Decision Date: 04/12/2002
Decision: 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: KXA
Date Received: 08/13/2001
Decision Date: 04/12/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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