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FDA 510(k) Application Details - K221546
Device Classification Name
More FDA Info for this Device
510(K) Number
K221546
Device Name
OneTouch Delica Plus Lancing System
Applicant
Asahi Polyslider Co., Ltd.
860-2 Misaki
Maniwa 719-3226 JP
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Contact
Yoshitaka Akagi
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QRL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2022
Decision Date
08/23/2022
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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