Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed2Product Code
- K171271Polyform Synthetic Mesh2Cleared 510(K)
- K150023Vertessa Lite Y-Mesh2Cleared 510(K)
- K150016Vertessa Lite2Cleared 510(K)
- K140116RESTORELLE Y CONTOUR MESH2Cleared 510(K)
- K132061RESTORELLE M, RESTORELLE XL2Cleared 510(K)
- K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH2Cleared 510(K)
- K123914RESTORELLE Y CONTOUR2Cleared 510(K)
- K123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM2Cleared 510(K)
- K122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-60152Cleared 510(K)
- K122794UPSYLON Y MESH2Cleared 510(K)
Show All 23 Submissions
- PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed2Product Code
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
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- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K122968
- 510(k) Type
- Traditional
- Applicant
- COLOPLAST CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/18/2012
- Days to Decision
- 84 days
- Submission Type
- Summary