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FDA 510(k) Application Details - K192335
Device Classification Name
Cement, Bone, Vertebroplasty
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510(K) Number
K192335
Device Name
Cement, Bone, Vertebroplasty
Applicant
GS Medical Co., Ltd.
90, Osongsaengmyeong 4-ro
Osong-eup, Cheongwon-gun 363-951 KR
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Contact
Andrea Watt
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
NDN
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More FDA Info for this Product Code
Date Received
08/28/2019
Decision Date
12/04/2019
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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