FDA-Device2013-05-29Class II
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Progressive Medical Inc
Hazard
Product coatings require 510K approval.
Sold states
Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
Affected count
38 boxes with 6 units each.
Manufactured in
997 Horan Dr, N/A, Fenton, MO, United States
Products
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2013Don't want to check this manually?
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