QUELL DESENSITIZER— 510(k) K010957
Substantially EquivalentJeneric/Pentron, Inc.
FDA 510(k) clearance K010957 for QUELL DESENSITIZER, Substantially Equivalent on 2001-06-25. Applicant: Jeneric/Pentron, Inc.. Device class: 2.
Clearance details
- Applicant
- Jeneric/Pentron, Inc.
- Product code
- Code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wallingford, CT, US
Recent devices under product code LBH
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