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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
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LQX
Device, Finger-Sucking
1
Product Code
K
94
5537
T-GUARD
1
Cleared 510(K)
K
86
4870
THUMBSHELPER POWER RING
1
Cleared 510(K)
Subpart D—Prosthetic Devices
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Subpart F—Therapeutic Devices
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Last synced on 30 November 2024 at 11:09 am
DE
/
subpart-d—physical-medicine-prosthetic-devices
/
LQX
/
K864870
View Source
THUMBSHELPER POWER RING
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864870
510(k) Type
Traditional
Applicant
LEVOLON COMPANY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/12/1987
Days to Decision
62 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
LQX
Device, Finger-Sucking
K
94
5537
T-GUARD
K
86
4870
THUMBSHELPER POWER RING
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-d—physical-medicine-prosthetic-devices
/
LQX
/
K864870
View Source
THUMBSHELPER POWER RING
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864870
510(k) Type
Traditional
Applicant
LEVOLON COMPANY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/12/1987
Days to Decision
62 days