510(k) K980849
K980849 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "SURGIN KIT". The FDA issued a decision of Substantially Equivalent on July 9, 1998. The device falls under product code MSR (Tubing, Replacement, Phacofragmentation Unit), a Class II device regulated under 21 CFR 886.4150. Surgin Surgical Instrumentation, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1998
- Date Received
- February 5, 1998
- 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