510(k) K874252

KREDA DISC by Richmond Products, Inc. — Product Code HOQ

K874252 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "KREDA DISC". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
October 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Amsler
Device Class
Class I
Regulation Number
886.1330
Review Panel
OP
Submission Type