FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOPICAL APPLICATOR
K Number: K070596
·
Decision Jun 21, 2007
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
4
Review Days
111
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Basic Information
- Device Name
- TOPICAL APPLICATOR
- K Number
- K070596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5170
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sharn, Inc.
- Date Received
- March 2, 2007
- Decision Date
- June 21, 2007
- Product Code
- CCT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | FDA class 2 | Anesthesiology |
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