510(k) K070596
K070596 is an FDA 510(k) premarket notification submitted by Sharn, Inc. for the device "TOPICAL APPLICATOR". The FDA issued a decision of Substantially Equivalent on June 21, 2007. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Sharn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2007
- Date Received
- March 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator (Laryngo-Tracheal), Topical Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5170
- Review Panel
- AN
- Submission Type