FDA 510(k) Application Details - K981296

Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

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510(K) Number K981296
Device Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Applicant GEEN HEALTHCARE, INC.
931 PROGRESS AVE., UNIT 13
SCARBOROUGH, ONTARIO M1G 3V5 CA
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Contact GREG W GEEN
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Regulation Number 880.5780

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Classification Product Code DWL
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Date Received 04/09/1998
Decision Date 05/29/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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