510(k) K012685
- Device
- REPROCESSED ENDOSCOPIC ELECTRODES
- Applicant
- STERILMED, INC.
- 510(k) number
- K012685
- Product code
- NLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-14
- Date received
- 2001-08-14
- Regulation
- 876.4300
- Classification name
- Electrode, Electrosurgical, Active, Urological, Reprocessed
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK FLEISCHHACKER
- Address
- 11400 73rd Ave. N Maple Grove MN US 55369 55369
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases