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510(k) K010852

Device
OSMED TISSUE EXPANDER
Applicant
IOP, INC.
510(k) number
K010852
Product code
NFM  
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-13
Date received
2001-03-21
Regulation
886.3320
Classification name
Expander, Tissue, Orbital
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JASON MALECKA
Address
3151 Airway Ave., Bldg. I-1 Costa Mesa CA US 92626 92626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NFM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060151ORBITAL TISSUE EXPANDER (OTE)Innovia, LLC2006-08-08

Legacy Summary#

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FDA Review#

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