510(k) K840101
K840101 is an FDA 510(k) premarket notification submitted by Truline Instruments, Inc. for the device "EYE SURGERY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code HOB (Clamp, Muscle, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1984
- Date Received
- January 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Muscle, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type