FDA 510(k) Application Details - K040912

Device Classification Name Plug, Punctum

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510(K) Number K040912
Device Name Plug, Punctum
Applicant PARTNERS IN BIOMATERIALS, INC.
466 WEST ARROW HWY., UNIT H
SAN DIMAS, CA 91773 US
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Contact JAMES CHRISTENSEN
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Regulation Number 000.0000

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Classification Product Code LZU
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Date Received 04/08/2004
Decision Date 11/16/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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