510(k) K965185

ACRYPAK FOLDER by Alcon Laboratories — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1997
Date Received
December 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type