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FDA 510(k) Application Details - K190610
Device Classification Name
Scalpel, Ultrasonic, Reprocessed
More FDA Info for this Device
510(K) Number
K190610
Device Name
Scalpel, Ultrasonic, Reprocessed
Applicant
Sterilmed, Inc.
5010 Cheshire Parkway N, Suite 2
Plymouth, MN 55446 US
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Contact
Jan Flegeau
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NLQ
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More FDA Info for this Product Code
Date Received
03/11/2019
Decision Date
08/15/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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