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FDA 510(k) Application Details - K071299
Device Classification Name
System, Image Management, Ophthalmic
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510(K) Number
K071299
Device Name
System, Image Management, Ophthalmic
Applicant
DIGITAL HEALTHCARE, LTD.
343 SOUTH WHITE ST.
WAKE FOREST, NC 27587 US
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Contact
GERRY SKEWS
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
NFJ
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More FDA Info for this Product Code
Date Received
05/09/2007
Decision Date
08/31/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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