FDA 510(k) Application Details - K021509

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K021509
Device Name Sleeve, Limb, Compressible
Applicant HYGIA HEALTH SERVICES, INC.
2800 MILAN CT., SUITE 259
BIRMINGHAM, AL 35211 US
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Contact GEOFF M FATZINGER
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 05/09/2002
Decision Date 12/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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