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FDA 510(k) Application Details - K053425
Device Classification Name
Ophthalmoscope, Battery-Powered
More FDA Info for this Device
510(K) Number
K053425
Device Name
Ophthalmoscope, Battery-Powered
Applicant
PRECISION OPTICS CORP.
22 EAST BROADWAY
GARDNER, MA 01440-3338 US
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Contact
ERWIN HEIDER
Other 510(k) Applications for this Contact
Regulation Number
886.1570
More FDA Info for this Regulation Number
Classification Product Code
HLJ
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More FDA Info for this Product Code
Date Received
12/08/2005
Decision Date
01/09/2006
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
Y
Expedited Review
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