FDA-Device2013-05-29Class II
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only 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
11 boxes with 25 units each.
Manufactured in
997 Horan Dr, N/A, Fenton, MO, United States
Products
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1364-2013Don't want to check this manually?
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