SPIRAFLO DIALYZER, DISPOSABLE— 510(k) K760797
Substantially EquivalentBentley Laboratories, Inc.
FDA 510(k) clearance K760797 for SPIRAFLO DIALYZER, DISPOSABLE, Substantially Equivalent on 1976-11-19. Applicant: Bentley Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bentley Laboratories, Inc.
- Product code
- Code EJT
- Device class
- Class 2
- Regulation
- 21 CFR 872.3060
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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