510(k) K053188
- Device
- REPROCESSED BALOON INFLATION DEVICE
- Applicant
- STERILMED, INC.
- 510(k) number
- K053188
- Product code
- NKU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-05-04
- Date received
- 2005-11-15
- Regulation
- 870.1650
- Classification name
- Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRUCE R LESTER
- Address
- 11400 73rd Ave. N Maple Grove MN US 55369 55369
Source Documents#
Legacy Summary#
summary
FDA Review#
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