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FDA 510(k) Application Details - K212291
Device Classification Name
System, X-Ray, Mobile
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510(K) Number
K212291
Device Name
System, X-Ray, Mobile
Applicant
Sedecal SA
C/ Pelaya, 9 - 13 Pol. Ind. Rφo De Janeiro
Algete 28110 ES
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Contact
M¬ Luisa G≤mez de Agⁿero
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Regulation Number
892.1720
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Classification Product Code
IZL
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More FDA Info for this Product Code
Date Received
07/22/2021
Decision Date
09/14/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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