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FDA Browser
by
Innolitics
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Assisted Reproduction Devices
CFR Sub-Part
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Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
HDX
Dilator, Vaginal
2
Product Code
K
21
1959
Milli Vaginal Dilator
2
Cleared 510(K)
K
13
0273
PANPAC VAGINAL DILATORS
2
Cleared 510(K)
K
07
1754
NEO-VAGINA SURGERY SET AND ACCESSORIES
2
Cleared 510(K)
K
00
3380
BIOTEQUE VAGINAL DILATOR
2
Cleared 510(K)
HFJ
Prosthesis, Fallopian Tube
2
Product Code
HFK
Mold, Vaginal
2
Product Code
HFL
Drain, Cervical
2
Product Code
HHW
Pessary, Vaginal
2
Product Code
KXP
Stent, Vaginal
2
Product Code
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Physical Medicine Prosthetic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
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CFR Sub-Part
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Review Panel
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Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
OB
/
obstetrical-and-gynecological-prosthetic-devices
/
HDX
/
K130273
View Source
PANPAC VAGINAL DILATORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130273
510(k) Type
Traditional
Applicant
Panpac Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
8/8/2013
Days to Decision
185 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
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
K
21
1959
Milli Vaginal Dilator
K
13
0273
PANPAC VAGINAL DILATORS
K
07
1754
NEO-VAGINA SURGERY SET AND ACCESSORIES
K
00
3380
BIOTEQUE VAGINAL DILATOR
HFJ
Prosthesis, Fallopian Tube
HFK
Mold, Vaginal
HFL
Drain, Cervical
HHW
Pessary, Vaginal
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
/
HDX
/
K130273
View Source
PANPAC VAGINAL DILATORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130273
510(k) Type
Traditional
Applicant
Panpac Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
8/8/2013
Days to Decision
185 days
Submission Type
Statement