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U.S. Department of Health and Human Services

Product Classification

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Device sleeve, limb, compressible
Regulation Description Compressible limb sleeve.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeJOW
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.5800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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