CARDIOPLEGIA COOLING & ADMIN. SETS— 510(k) K811368
Substantially EquivalentBentley Laboratories, Inc.
FDA 510(k) clearance K811368 for CARDIOPLEGIA COOLING & ADMIN. SETS, Substantially Equivalent on 1981-06-09. Applicant: Bentley Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Bentley Laboratories, Inc.
- Product code
- Code KRI
- Device class
- Class 1
- Regulation
- 21 CFR 870.4200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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