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Manufacturers
US
Leica, Inc.
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Medical Device Manufacturer
·
US , Buffalo , NY
Leica, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1992
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Leica, Inc.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 22, 1995
XCEL SLIT LAMP
K951054
·
HJO
Ophthalmic
·
15d
Cleared
Nov 17, 1994
LENSCHEK
K944022
·
HLM
Ophthalmic
·
92d
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3
Ophthalmic
2
Chemistry
1