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Review Panel
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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
EAJ
Apron, Leaded
1
Product Code
EAK
Screen, Leaded, Operator Radiation Protector
1
Product Code
IWO
Apron, Protective
1
Product Code
IWP
Radiographic Protective Glove
1
Product Code
IWQ
Curtain, Protective, Radiographic
1
Product Code
IWR
Holder, Syringe, Lead
1
Product Code
IWS
Shield, Eye, Radiological
1
Product Code
K
94
5515
COATED TUNGSTEN EYESHIELD
1
Cleared 510(K)
K
94
0119
ROYAL MARSDEN GOLD GRAIN GUN
1
Cleared 510(K)
K
94
3011
TUNGSTEN EYESHIELD
1
Cleared 510(K)
K
93
4459
MED-GENESIS PATIENT LASER EYE SHIELD
1
Cleared 510(K)
K
93
4362
NUCLEAR ASSOCIATES GLASSERS
1
Cleared 510(K)
K
92
0540
RADIOLOGICAL PROTECTIVE EYE SHIELD
1
Cleared 510(K)
IWT
Shield, Gonadal
1
Product Code
IWW
Shield, Vial
1
Product Code
IWX
Barrier, Control Panel, X-Ray, Movable
1
Product Code
KPY
Shield, Protective, Personnel
1
Product Code
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
RA
/
subpart-g—miscellaneous-devices
/
IWS
/
K943011
View Source
TUNGSTEN EYESHIELD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K943011
510(k) Type
Traditional
Applicant
MEDTEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/1994
Days to Decision
182 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
EAJ
Apron, Leaded
EAK
Screen, Leaded, Operator Radiation Protector
IWO
Apron, Protective
IWP
Radiographic Protective Glove
IWQ
Curtain, Protective, Radiographic
IWR
Holder, Syringe, Lead
IWS
Shield, Eye, Radiological
K
94
5515
COATED TUNGSTEN EYESHIELD
K
94
0119
ROYAL MARSDEN GOLD GRAIN GUN
K
94
3011
TUNGSTEN EYESHIELD
K
93
4459
MED-GENESIS PATIENT LASER EYE SHIELD
K
93
4362
NUCLEAR ASSOCIATES GLASSERS
K
92
0540
RADIOLOGICAL PROTECTIVE EYE SHIELD
IWT
Shield, Gonadal
IWW
Shield, Vial
IWX
Barrier, Control Panel, X-Ray, Movable
KPY
Shield, Protective, Personnel
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-g—miscellaneous-devices
/
IWS
/
K943011
View Source
TUNGSTEN EYESHIELD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K943011
510(k) Type
Traditional
Applicant
MEDTEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/1994
Days to Decision
182 days
Submission Type
Statement