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Ear, Nose, Throat
2016
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818
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795
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510k Database
Manufacturers
US
Rockwin Corp.
Medical Device Manufacturer
·
US , Dekalb , IL
Rockwin Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1994
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rockwin Corp.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 12, 1997
HI-69E, HI-69N, HI-69P
K974129
·
ESD
Ear, Nose, Throat
·
39d
Cleared
May 24, 1995
RIONET HM-02
K943808
·
ESD
Ear, Nose, Throat
·
293d
Cleared
Jan 27, 1994
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
K935559
·
ESD
Ear, Nose, Throat
·
71d
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3
Ear, Nose, Throat
3