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PIVOTAL SCISSOR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972510
510(k) Type
Traditional
Applicant
UROHEALTH SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/13/1997
Days to Decision
133 days
Submission Type
Summary

PIVOTAL SCISSOR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972510
510(k) Type
Traditional
Applicant
UROHEALTH SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/13/1997
Days to Decision
133 days
Submission Type
Summary