510(k) K853727

KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) by Ryder Intl. Corp. — Product Code LRX

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