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APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082387
510(k) Type
Special
Applicant
AMERICAN MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2008
Days to Decision
107 days
Submission Type
Summary

APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082387
510(k) Type
Special
Applicant
AMERICAN MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2008
Days to Decision
107 days
Submission Type
Summary