510(k) K883199

MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM by Chiron Vision Corp. — Product Code HQC

K883199 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 15, 1988. 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
September 15, 1988
Date Received
July 28, 1988
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