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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
IWT
Shield, Gonadal
1
Product Code
K
93
0763
FIGLEAF SHIELD
1
Cleared 510(K)
K
83
3523
C.B. RADIOLOGY DESIGN GONADSHIELD
1
Cleared 510(K)
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
/
IWT
/
K930763
View Source
FIGLEAF SHIELD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930763
510(k) Type
Traditional
Applicant
BYERS INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/1993
Days to Decision
94 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
IWT
Shield, Gonadal
K
93
0763
FIGLEAF SHIELD
K
83
3523
C.B. RADIOLOGY DESIGN GONADSHIELD
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
/
IWT
/
K930763
View Source
FIGLEAF SHIELD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930763
510(k) Type
Traditional
Applicant
BYERS INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/1993
Days to Decision
94 days
Submission Type
Statement