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510k Database
Manufacturers
KR
Roen Surgical, Inc.
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Medical Device Manufacturer
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KR , Daejeon
Roen Surgical, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
Recent clearances:
Zamenix™ P
View 1 510(k) Devices ↓
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roen Surgical, Inc.
General & Plastic Surgery
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1
devices
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Cleared
Aug 07, 2026
Zamenix™ P
K253505
·
FGB
General & Plastic Surgery
·
280d
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General & Plastic Surgery
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