Last synced on 30 September 2022 at 11:05 pm

GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K013718
510(k) Type
Traditional
Applicant
GYNECARE, A DIV. OF ETHICON, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/8/2002
Days to Decision
61 days
Submission Type
Summary

GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K013718
510(k) Type
Traditional
Applicant
GYNECARE, A DIV. OF ETHICON, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/8/2002
Days to Decision
61 days
Submission Type
Summary