510(k) K970727

MPORT FOLDABLE LENS PLACEMENT SYSTEM by Chiron Vision Corp. — Product Code MSS

K970727 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "MPORT FOLDABLE LENS PLACEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 17, 1997. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
February 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type