510(k) K932230

CRYSTAL VISION AND ACCESSORIES by I.C Medical, Inc. — Product Code FYD

K932230 is an FDA 510(k) premarket notification submitted by I.C Medical, Inc. for the device "CRYSTAL VISION AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. I.C Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1994
Date Received
May 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type