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U.S. Department of Health and Human Services

Product Classification
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Device defoamer, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass defoamer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTP
Submission Type 510(k)
Regulation Number 870.4230
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA
Third Party Review Not Third Party Eligible
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