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FDA 510(k) Application Details - K053622
Device Classification Name
Prosthesis, Eyelid Spacer/Graft, Biologic
More FDA Info for this Device
510(K) Number
K053622
Device Name
Prosthesis, Eyelid Spacer/Graft, Biologic
Applicant
IOP, INC.
3184 AIRWAY AVE., BLDG. B
COSTA MESA, CA 92626 US
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Contact
JASON MALECKA
Other 510(k) Applications for this Contact
Regulation Number
886.3130
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Classification Product Code
NXM
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More FDA Info for this Product Code
Date Received
12/28/2005
Decision Date
03/15/2006
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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