510(k) K853727
K853727 is an FDA 510(k) premarket notification submitted by Ryder Intl. Corp. for the device "KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE)". The FDA issued a decision of Substantially Equivalent on February 7, 1986. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Ryder Intl. Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1986
- Date Received
- September 6, 1985
- 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