SR-ISOCETTE— 510(k) K811665
Substantially EquivalentJ. Aderer, Inc.
FDA 510(k) clearance K811665 for SR-ISOCETTE, Substantially Equivalent on 1981-07-15. Applicant: J. Aderer, Inc.. Device class: 1.
Clearance details
- Applicant
- J. Aderer, Inc.
- Product code
- Code ELK
- Device class
- Class 1
- Regulation
- 21 CFR 872.3910
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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