ADAPTOR HR-3000 REUSE— 510(k) K841153
Substantially EquivalentColorado Medical, Inc.
FDA 510(k) clearance K841153 for ADAPTOR HR-3000 REUSE, Substantially Equivalent on 1984-07-16. 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
- Walker, MI, US
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