FDA 510(k) Application Details - K022043

Device Classification Name Plug, Punctum

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510(K) Number K022043
Device Name Plug, Punctum
Applicant MEDENNIUM, INC.
15350 BARRANCA PKWY.
IRVINE, CA 92618 US
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Contact JULIAN ABADIA
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Regulation Number 000.0000

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Classification Product Code LZU
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Date Received 06/24/2002
Decision Date 10/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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