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FDA 510(k) Application Details - K202822
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
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510(K) Number
K202822
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
Metaltronica Spa
66 via delle Monachelle
Pomezia RM CAP 00071 IT
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Contact
Gloria Pesce Delfino
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MUE
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More FDA Info for this Product Code
Date Received
09/24/2020
Decision Date
12/15/2021
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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