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FDA 510(k) Application Details - K142486
Device Classification Name
Ophthalmoscope, Battery-Powered
More FDA Info for this Device
510(K) Number
K142486
Device Name
Ophthalmoscope, Battery-Powered
Applicant
HEINE Optotechnik GmbH & Co. KG
Kientalstr. 7
Herrsching 82211 DE
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Contact
Bettina Seim
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
09/04/2014
Decision Date
05/18/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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