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FDA 510(k) Application Details - K182774
Device Classification Name
More FDA Info for this Device
510(K) Number
K182774
Device Name
STOP U (Packed Black USA), STOP U (Packed White USA)
Applicant
Pollogen Ltd.
6 Kaufman St.
Tel Aviv 6801298 IL
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Contact
Einat Shammai
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PAY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2018
Decision Date
06/19/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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