510(k) K862343
K862343 is an FDA 510(k) premarket notification submitted by Cutler Medical Instruments for the device "VACUUM HANDLE MODEL I/A - 1". The FDA issued a decision of Substantially Equivalent on Jul 11, 1986. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Cutler Medical Instruments has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 1986
- Date Received
- Jun 20, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type
- 510(k)