510(k) K944994

IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE by Chiron Vision Corp. — Product Code HQC

K944994 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE". The FDA issued a decision of Substantially Equivalent on March 14, 1995. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1995
Date Received
October 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type