Atlas FDA

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

FDA 510(k) clearance K183616 · decided 2019-01-10

Clearance details

K-number
K183616
Device name
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
Applicant
M.I.Tech Co., Ltd.
Decision
Substantially Equivalent
Date received
2018-12-26
Decision date
2019-01-10
Days to decision
15 days
Clearance type
Traditional
Product code
MQR
Device class
2
Regulation number
878.3610
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Pyeongtaek-Si, KR
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

No recalls on record reference this clearance.