HR-3000 REUSE ADAPTOR— 510(k) K870689
Substantially EquivalentColorado Medical, Inc.
FDA 510(k) clearance K870689 for HR-3000 REUSE ADAPTOR, Substantially Equivalent on 1987-04-10. Applicant: Colorado Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Colorado Medical, Inc.
- Product code
- Code LIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Evergreen, CO, US
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