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435
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362
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270
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266
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Manufacturers
DE
Scopis GmbH
Medical Device Manufacturer
·
DE , Berlin
Scopis GmbH - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scopis GmbH
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 27, 2017
Scopis Extended Instrument Set EM
K171661
·
PGW
Ear, Nose, Throat
·
114d
Cleared
Feb 09, 2017
Scopis Hybrid Navigation System EM
K161491
·
PGW
Ear, Nose, Throat
·
253d
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Ear, Nose, Throat
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