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FDA Browser
by
Innolitics
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
MRH
Pump, Infusion, Ophthalmic
2
Product Code
K
21
2797
iPrime Viscodelivery System
2
Cleared 510(K)
K
21
1680
Streamline Surgical System
2
Cleared 510(K)
K
20
2678
OMNI Surgical System
2
Cleared 510(K)
K
20
1953
OMNI PLUS Surgical System
2
Cleared 510(K)
K
17
3332
OMNI Surgical System
2
Cleared 510(K)
K
17
1905
VISCO 360 Viscosurgical System
2
Cleared 510(K)
K
14
3205
Viscoelastic Injector
2
Cleared 510(K)
K
13
2494
VISCOELASTIC INJECTOR
2
Cleared 510(K)
K
05
0716
ISCIENCE SURGICAL VISCOINJECTOR
2
Cleared 510(K)
K
00
0420
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
2
Cleared 510(K)
Show All 16 Submissions
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
OP
/
general-hospital-and-personal-use-therapeutic-devices
/
MRH
/
K000420
View Source
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000420
510(k) Type
Traditional
Applicant
RETINALABS.COM
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2000
Days to Decision
90 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
General Hospital and Personal Use Therapeutic Devices
MRH
Pump, Infusion, Ophthalmic
K
21
2797
iPrime Viscodelivery System
K
21
1680
Streamline Surgical System
K
20
2678
OMNI Surgical System
K
20
1953
OMNI PLUS Surgical System
K
17
3332
OMNI Surgical System
K
17
1905
VISCO 360 Viscosurgical System
K
14
3205
Viscoelastic Injector
K
13
2494
VISCOELASTIC INJECTOR
K
05
0716
ISCIENCE SURGICAL VISCOINJECTOR
K
00
0420
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
Show All 16 Submissions
Miscellaneous
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
general-hospital-and-personal-use-therapeutic-devices
/
MRH
/
K000420
View Source
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000420
510(k) Type
Traditional
Applicant
RETINALABS.COM
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2000
Days to Decision
90 days
Submission Type
Summary