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FDA 510(k) Application Details - K032104
Device Classification Name
Conformer, Ophthalmic, Biological Tissue
More FDA Info for this Device
510(K) Number
K032104
Device Name
Conformer, Ophthalmic, Biological Tissue
Applicant
BIO-TISSUE, INC.
1301 K STREET, N.W.
WASHINGTON, DC 20005 US
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Contact
DAVID J BLOCH
Other 510(k) Applications for this Contact
Regulation Number
886.3130
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Classification Product Code
NQB
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More FDA Info for this Product Code
Date Received
07/08/2003
Decision Date
12/12/2003
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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