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horizonal rule
Dockets Management


Volume 1

Reclassification Petition

Letter from CDRH to McCue Corporation, Inc.

Letter from CDRH to CooperSurgical, Inc.

515(i) Reclassification Letter to Manufacturers http://www.fda.gov/cdrh/ode/515iltr.html

Premarket Approval (PMA) Database search results for product code MUA

Appendix 1 - Similar Devices with Approval/Clearance

Appendix 2 - Summary of Valid Scientific Evidence Supporting Recommendation

Appendix 3 - Bibliography of Published Literature
References Published Material

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