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FDA 510(k) Application Details - K970319
Device Classification Name
Conformer, Ophthalmic
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510(K) Number
K970319
Device Name
Conformer, Ophthalmic
Applicant
XAVIER A. GUERRA, OCULARIST, INC.
4640 CENTERVIEW DR.
SAN ANTONIO, TX 78228 US
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Contact
XAVIER A GUERRA
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Regulation Number
886.3130
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Classification Product Code
HQN
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More FDA Info for this Product Code
Date Received
01/28/1997
Decision Date
07/07/1997
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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