510(k) K971439

STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES by Storz Instrument Co. — Product Code HQC

K971439 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES". The FDA issued a decision of Substantially Equivalent on June 17, 1997. 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
June 17, 1997
Date Received
April 18, 1997
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