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FDA 510(k) Application Details - K974635
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K974635
Device Name
Case, Contact Lens
Applicant
PARAGON VISION SCIENCES
947 EAST IMPALA AVE.
MESA, AZ 85204 US
Other 510(k) Applications for this Company
Contact
WILLIAM E MEYERS
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/1997
Decision Date
02/04/1998
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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