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FDA 510(k) Application Details - K190875
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K190875
Device Name
Unit, Phacofragmentation
Applicant
D.O.R.C. Dutch Ophthalmic Research Center (International)
B.V.
Scheijdelveweg 2
Zuidland 3214 VN NL
Other 510(k) Applications for this Company
Contact
Linda Van Leeuwen
Other 510(k) Applications for this Contact
Regulation Number
886.4670
More FDA Info for this Regulation Number
Classification Product Code
HQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/04/2019
Decision Date
09/25/2019
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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