510(k) K854225
K854225 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology, Inc. for the device "ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS". The FDA issued a decision of Substantially Equivalent on Dec 27, 1985. 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
- Dec 27, 1985
- Date Received
- Oct 18, 1985
- 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)