FDA 510(k) Application Details - K070496

Device Classification Name Splint, Intranasal Septal

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510(K) Number K070496
Device Name Splint, Intranasal Septal
Applicant CARBYLAN BIOSURGERY
3181 PORTER DRIVE
PALO ALTO, CA 94304 US
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Contact ROXANNE DUBOIS
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Regulation Number 874.4780

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Classification Product Code LYA
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Date Received 02/20/2007
Decision Date 03/15/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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