510(k) K881094

KOI(TM) BLADE GAUGE, MODEL KOI-132 by CooperVision, Inc. — Product Code HOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1988
Date Received
March 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Caliper, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type