TOPICAL APPLICATOR— 510(k) K070596
Substantially EquivalentSharn, Inc.
FDA 510(k) clearance K070596 for TOPICAL APPLICATOR, Substantially Equivalent on 2007-06-21. Applicant: Sharn, Inc.. Device class: 2.
Clearance details
- Applicant
- Sharn, Inc.
- Product code
- Code CCT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5170
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
Recent devices under product code CCT
view allMore clearances from Sharn, Inc.
view allAdverse events under product code CCT
product code CCT- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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