FDA 510(k) Application Details - K971036

Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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510(K) Number K971036
Device Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Applicant INTERPORE INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact MARIO GERSBERG
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Regulation Number 878.4680

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Classification Product Code GCY
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Date Received 03/20/1997
Decision Date 06/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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