510(k) K960003

STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION by Storz Instrument Co. — Product Code HQC

K960003 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION". The FDA issued a decision of Substantially Equivalent on August 29, 1996. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
January 2, 1996
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