510(k) K871741
K871741 is an FDA 510(k) premarket notification submitted by Eaton Medical Corp. for the device "EASY EYES TM LENS CARRYING CASE". The FDA issued a decision of Substantially Equivalent on July 22, 1987. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Eaton Medical Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1987
- Date Received
- May 5, 1987
- 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