510(k) K102563
K102563 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "SINGLE CANNULA EXTENDED APPLICATOR". The FDA issued a decision of Substantially Equivalent on March 15, 2011. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Micromedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2011
- Date Received
- September 7, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Irrigating (Non Dental)
- Device Class
- Class I
- Regulation Number
- 880.6960
- Review Panel
- HO
- Submission Type