510(k) K897085
K897085 is an FDA 510(k) premarket notification submitted by Magnivision, Inc. for the device "COMFEES(R) + CON-PAK(TM) LENS CASE". The FDA issued a decision of Substantially Equivalent on February 28, 1990. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Magnivision, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1990
- Date Received
- December 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type