TOPICAL APPLICATOR
FDA 510(k) clearance K070596 · decided 2007-06-21
Clearance details
- K-number
- K070596
- Device name
- TOPICAL APPLICATOR
- Applicant
- Sharn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-02
- Decision date
- 2007-06-21
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- CCT
- Device class
- 2
- Regulation number
- 868.5170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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