510(k) K870164
K870164 is an FDA 510(k) premarket notification submitted by Dayton Mfg. Co. for the device "SUMMIT OPTICS SOFT CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on February 10, 1987. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Dayton Mfg. Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1987
- Date Received
- January 14, 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