FDA 510(k) Application Details - K000151

Device Classification Name Ocular Peg

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510(K) Number K000151
Device Name Ocular Peg
Applicant INTEGRATED ORBITAL IMPLANTS, INC.
4329 GRAYDON RD.
SAN DIEGO, CA 92130 US
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Contact FLOYD G LARSON
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Regulation Number 886.3320

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Classification Product Code MQU
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Date Received 01/19/2000
Decision Date 04/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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