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FDA 510(k) Application Details - K970327
Device Classification Name
Shell, Scleral
More FDA Info for this Device
510(K) Number
K970327
Device Name
Shell, Scleral
Applicant
SOUTHWEST ARTIFICIAL EYES, INC.
4640 CENTERVIEW
SAN ANTONIO, TX 78228 US
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Contact
DANIEL M WENSKE
Other 510(k) Applications for this Contact
Regulation Number
886.3800
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Classification Product Code
HQT
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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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