510(k) K012556
- Device
- REPROCESSED GUIDEWIRES
- Applicant
- STERILMED, INC.
- 510(k) number
- K012556
- Product code
- NML
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-04-29
- Date received
- 2001-08-08
- Regulation
- 876.5010
- Classification name
- Catheter, Biliary, 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#
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