510(k) K965127
K965127 is an FDA 510(k) premarket notification submitted by Dgh Technology, Inc. for the device "DGH MODEL 9000". The FDA issued a decision of Substantially Equivalent on Mar 17, 1997. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Dgh Technology, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 17, 1997
- Date Received
- Dec 23, 1996
- 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)