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FDA 510(k) Application Details - K963010
Device Classification Name
Lens, Contact (Other Material) - Daily
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510(K) Number
K963010
Device Name
Lens, Contact (Other Material) - Daily
Applicant
PERMEABLE TECHNOLOGIES, INC.
6 SHADOWBROOK DR.
COLTS NECK, NJ 07722 US
Other 510(k) Applications for this Company
Contact
MARTIN S KNOPF
Other 510(k) Applications for this Contact
Regulation Number
886.5916
More FDA Info for this Regulation Number
Classification Product Code
HQD
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More FDA Info for this Product Code
Date Received
08/02/1996
Decision Date
11/20/1996
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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