510(k) K862777
K862777 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology, Inc. for the device "MODEL A-8000 ULTRASONIC HANDPIECE CORD". The FDA issued a decision of Substantially Equivalent on Aug 11, 1986. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Advanced Medical Technology, Inc. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 1986
- Date Received
- Jul 22, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type
- 510(k)