FDA 510(k) Application Details - K963501

Device Classification Name Plug, Punctum

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510(K) Number K963501
Device Name Plug, Punctum
Applicant LACRIMEDICS, INC.
190 NORTH ARROWHEAD AVE.,
SUITE B
RIALTO, CA 92376 US
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Contact ROBERT S HERRICK
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Regulation Number 000.0000

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Classification Product Code LZU
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Date Received 09/03/1996
Decision Date 04/14/1997
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

FDA Source Information for K963501


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