510(k) K862777

MODEL A-8000 ULTRASONIC HANDPIECE CORD by Advanced Medical Technology, Inc. — Product Code HQC

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 August 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 at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1986
Date Received
July 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