510(k) K990292
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN by
Ophthalmic Consultants, Inc.
— Product Code HQE
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1999
- Date Received
- January 29, 1999
- 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