FDA 510(k) Application Details - K992954

Device Classification Name Unit, Cryophthalmic, Ac-Powered

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510(K) Number K992954
Device Name Unit, Cryophthalmic, Ac-Powered
Applicant KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL, PA 19008 US
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Contact EUGENE R VAN ARSDALE
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Regulation Number 886.4170

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Classification Product Code HRN
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Date Received 09/01/1999
Decision Date 12/21/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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