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FDA 510(k) Application Details - K211667
Device Classification Name
N-Acetylprocainamide Control Materials
More FDA Info for this Device
510(K) Number
K211667
Device Name
N-Acetylprocainamide Control Materials
Applicant
Changzhou Universal Medical Equipment Co. Ltd
No. 6, Xinxi Road, Xinbei District
Changzhou 213000 CN
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Contact
Jerry Gao
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Regulation Number
862.3280
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Classification Product Code
LAZ
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More FDA Info for this Product Code
Date Received
06/01/2021
Decision Date
09/23/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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