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FDA 510(k) Application Details - K193099
Device Classification Name
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510(K) Number
K193099
Device Name
Anatomical Shoulder System
Applicant
Zimmer GmbH
Sulzerallee 8
Winterthur 8404 CH
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Contact
Roberto Tommasini
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Regulation Number
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Classification Product Code
PHX
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Date Received
11/07/2019
Decision Date
01/29/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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