510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1681
Chemistry
368
Dental
1339
Ear, Nose, Throat
249
Gastroenterology & Urology
977
General & Plastic Surgery
2196
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2943
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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M. Imonti and Associates Inc.,
Medical Device Manufacturer
·
US , San Juan Capistrano , CA
M. Imonti and Associates Inc., - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1991
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - M. Imonti and Associates Inc.,
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
May 22, 1995
PRO-PAK FOR OMS DIPLOMATE
K950800
·
HQC
Ophthalmic
·
90d
Cleared
Apr 28, 1995
PRO-VIT
K950799
·
HQE
Ophthalmic
·
66d
Cleared
Jan 25, 1994
PHACOFRAGMENTOR TIP
K933627
·
HQC
Ophthalmic
·
182d
Cleared
Jan 06, 1994
PRO-PHACO HANDPIECE
K933503
·
HQC
Ophthalmic
·
171d
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6
Ophthalmic
4
General & Plastic Surgery
1
Anesthesiology
1