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U.S. Department of Health and Human Services

Product Classification

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Device wrap, sterilization
Regulation Description Sterilization wrap.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFRG
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA
Third Party Review
Accredited Persons

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