FDA 510(k) Application Details - K970441

Device Classification Name Strip, Adhesive, Closure, Skin

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510(K) Number K970441
Device Name Strip, Adhesive, Closure, Skin
Applicant MEDI-FLEX HOSPITAL PRODUCTS, INC.
8717 W. 110TH ST., SUITE 750
OVERLAND PARK, KS 66210-2103 US
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Contact PAT MCGRATH
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Regulation Number 000.0000

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Classification Product Code FPX
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Date Received 02/05/1997
Decision Date 05/09/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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