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FDA 510(k) Application Details - K220917
Device Classification Name
Lancet, Blood
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510(K) Number
K220917
Device Name
Lancet, Blood
Applicant
GRI-Alleset, Inc.
4142 Industry Way
Flowery Branch, GA 314031 US
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Contact
Marty D Paugh
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Regulation Number
878.4800
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Classification Product Code
FMK
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More FDA Info for this Product Code
Date Received
03/30/2022
Decision Date
05/18/2022
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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