510(k) K873824

RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 by Applied Laboratories, Inc. — Product Code LRX

K873824 is an FDA 510(k) premarket notification submitted by Applied Laboratories, Inc. for the device "RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Applied Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
September 21, 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