FDA 510(k) Application Details - K240178

Device Classification Name

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510(K) Number K240178
Device Name RFG-01
Applicant Zimmer MedizinSysteme GmbH
Junkersstrasse 9
Neu-Ulm 89231 DE
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Contact Ute Killet
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Regulation Number

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Classification Product Code PBX
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Date Received 01/23/2024
Decision Date 07/15/2024
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

FDA Source Information for K240178


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