510k
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Anesthesiology
506
Cardiovascular
1577
Chemistry
355
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1263
Ear, Nose, Throat
233
Gastroenterology & Urology
911
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2093
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1774
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126
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91
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8
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445
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916
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417
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265
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2672
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49
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502
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2278
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154
Categories
LZA
Polymer Patient Examination Glove
355
LLZ
System, Image Processing,...
348
GEX
Powered Laser Surgical Instrument
346
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
232
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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The Laryngeal Mask Co., Ltd.
Medical Device Manufacturer
·
US , San Diego , CA
The Laryngeal Mask Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2000
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - The Laryngeal Mask Co., Ltd.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
May 09, 2007
LMA STONEBREAKER DEVICE
K062475
·
FFK
Gastroenterology & Urology
·
258d
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4
Anesthesiology
3
Gastroenterology & Urology
1