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U.S. Department of Health and Human Services

Product Classification
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Device ring, annuloplasty
Regulation Description Annuloplasty ring.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRH
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.3800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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