DIFF 4 SYSTEM— 510(k) K830441
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K830441 for DIFF 4 SYSTEM, Substantially Equivalent on 1983-05-16. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code EKZ
- Device class
- Class 2
- Regulation
- 21 CFR 872.4920
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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