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FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964441
510(k) Type
Traditional
Applicant
GYNECARE INNOVATION CENTER
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/28/1997
Days to Decision
142 days
Submission Type
Summary

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964441
510(k) Type
Traditional
Applicant
GYNECARE INNOVATION CENTER
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/28/1997
Days to Decision
142 days
Submission Type
Summary