CARDIOPULMONARY BYPASS ACCESSORY EQUIP.— 510(k) K811348
Substantially EquivalentBentley Laboratories, Inc.
FDA 510(k) clearance K811348 for CARDIOPULMONARY BYPASS ACCESSORY EQUIP., Substantially Equivalent on 1981-05-29. 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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