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FDA Browser
by
Innolitics
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Solution, Cold Sterilizing
2
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1
Product Code
K
09
0457
ORALUBE
1
Cleared 510(K)
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Unknown
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Last synced on 26 May 2023 at 11:04 pm
DE
/
general-hospital-and-personal-use-miscellaneous-devices
/
ONK
/
K090457
View Source
ORALUBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K090457
510(k) Type
Traditional
Applicant
PULPDENT CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/21/2009
Days to Decision
87 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Diagnostic Devices
General Hospital and Personal Use Miscellaneous Devices
LFE
Solution, Cold Sterilizing
ONK
Oral Lubricant
K
09
0457
ORALUBE
Miscellaneous
Miscellaneous Devices
Physical Medicine Diagnostic Devices
Physical Medicine Prosthetic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic 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
/
general-hospital-and-personal-use-miscellaneous-devices
/
ONK
/
K090457
View Source
ORALUBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K090457
510(k) Type
Traditional
Applicant
PULPDENT CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/21/2009
Days to Decision
87 days
Submission Type
Summary