510(k) K993361
K993361 is an FDA 510(k) premarket notification submitted by Hurricane Medical for the device "TUBING EXTENSION SET". The FDA issued a decision of Substantially Equivalent on January 4, 2000. The device falls under product code MSR (Tubing, Replacement, Phacofragmentation Unit), a Class II device regulated under 21 CFR 886.4150. Hurricane Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2000
- Date Received
- October 6, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Replacement, Phacofragmentation Unit
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type