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U.S. Department of Health and Human Services

Product Classification
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Device chamber, oxygen, topical, extremity
Regulation Description Topical oxygen chamber for extremities.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeKPJ
Submission Type 510(k)
Regulation Number 878.5650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities
Third Party Review Not Third Party Eligible
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