510(k) K870278

CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695 by Ryder Intl. Corp. — Product Code LPN

K870278 is an FDA 510(k) premarket notification submitted by Ryder Intl. Corp. for the device "CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code LPN (Accessories, Soft Lens Products), 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 20, 1987
Date Received
January 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type