FDA 510(k) Application Details - K960189

Device Classification Name Cushion, Flotation

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510(K) Number K960189
Device Name Cushion, Flotation
Applicant SPAN-AMERICA MEDICAL SYSTEMS, INC.
70 COMMERCE DR.
P.O. BOX 5231
GREENVILLE, SC 29615 US
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Contact WANDA TOTTON
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Regulation Number 890.3175

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Classification Product Code KIC
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Date Received 01/16/1996
Decision Date 02/07/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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