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Innolitics
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19
0277
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18
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17
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15
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15
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13
2313
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K
13
2670
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K
13
1198
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K
09
2981
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2
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K
08
3769
MODIFICATION TO URESTA PESSARY
2
Cleared 510(K)
Show All 34 Submissions
KXP
Stent, Vaginal
2
Product Code
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
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Last synced on 2 June 2023 at 11:04 pm
OB
/
obstetrical-and-gynecological-prosthetic-devices
/
HHW
/
K131198
View Source
TIPI OTC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131198
510(k) Type
Traditional
Applicant
CONTIPI LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/2013
Days to Decision
123 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
Assisted Reproduction Devices
Cardiovascular Monitoring Devices
Cardiovascular Prosthetic Devices
Clinical Chemistry Test Systems
Diagnostic Devices
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
Obstetrical and Gynecological Monitoring Devices
Obstetrical and Gynecological Prosthetic Devices
HDX
Dilator, Vaginal
HFJ
Prosthesis, Fallopian Tube
HFK
Mold, Vaginal
HFL
Drain, Cervical
HHW
Pessary, Vaginal
K
19
0277
ProVate Vaginal Support
K
18
3468
Revive Reusable Bladder Support
K
17
3351
Panpac Flexi Shelf Pessary
K
15
3422
Panpac Disposable Pessary Fitting Set
K
15
1413
Always/Tampax bladder supports
K
13
2313
PESSARY
K
13
2670
PANPAC INFLATABLE DOCUT PESSARY
K
13
1198
TIPI OTC
K
09
2981
PANPAC VAGINAL PESSARY
K
08
3769
MODIFICATION TO URESTA PESSARY
Show All 34 Submissions
KXP
Stent, Vaginal
Obstetrical and Gynecological Surgical Devices
Obstetrical and Gynecological Therapeutic Devices
Physical Medicine Prosthetic Devices
Prosthetic Devices
Therapeutic Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
obstetrical-and-gynecological-prosthetic-devices
/
HHW
/
K131198
View Source
TIPI OTC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131198
510(k) Type
Traditional
Applicant
CONTIPI LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/2013
Days to Decision
123 days
Submission Type
Summary