FDA 510(k) Application Details - K022842

Device Classification Name Hook, Ophthalmic

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510(K) Number K022842
Device Name Hook, Ophthalmic
Applicant STEPHENS INSTRUMENTS
2500 SANDERSVILLE RD.
LEXINGTON, KY 40511 US
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Contact ARCHALA JOHNSON
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Regulation Number 886.4350

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Classification Product Code HNQ
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Date Received 08/27/2002
Decision Date 11/01/2002
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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