Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- FPXStrip, Adhesive, Closure, Skin1Product Code
- FPYSheet, Burn1Product Code
- K930759CP & S STERILE BURN SHEET1Cleared 510(K)
- K926290BURN SHEET1Cleared 510(K)
- K921471BURNSHIELD TRAUMA DRESSING1Cleared 510(K)
- K921470BURNSHIELD FIRE BLANKET1Cleared 510(K)
- K900443BURNS CASUALTY SHEET LIMB WRAP1Cleared 510(K)
- K900442BURNS CASUALTY SHEET BURN ROLL1Cleared 510(K)
- K900441BURNS CASUALTY SHEET1Cleared 510(K)
- K871740LYOSHEET SURGICAL SHEET FOR BURNS1Cleared 510(K)
- K853145KENDALL CURITY BURN PAD1Cleared 510(K)
- K841898FIRST RESPONSE EMERG. MEDICSL - BURNS1Cleared 510(K)
Show All 17 Submissions
- KGXTape And Bandage, Adhesive1Product Code
- KMFBandage, Liquid1Product Code
- LRSI.V. Start Kit2Product Code
- MCYWound Dressing Kit2Product Code
- MHWDressing, Compression1Product Code
- NECBandage, Liquid, Skin Protectant1Product Code
- OXQDressing Change Tray1Product Code
- PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use1Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BURNSHIELD TRAUMA DRESSING
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K921471
- 510(k) Type
- Traditional
- Applicant
- LEVTRADE INTL. (PTY) LTD.
- Country
- South Africa
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/20/1993
- Days to Decision
- 389 days
- Submission Type
- Statement