FDA 510(k) Application Details - K040042

Device Classification Name Elastomer, Silicone Block

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510(K) Number K040042
Device Name Elastomer, Silicone Block
Applicant MEDISIL CORPORATION
1735 N. OLIVE STREET
VENTURA, CA 93001 US
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Contact ALASTAIR WINN
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Regulation Number 874.3620

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Classification Product Code MIB
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Date Received 01/12/2004
Decision Date 04/01/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K040042


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