510(k) K897119

GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP by Grieshaber & Co. — Product Code HQW

K897119 is an FDA 510(k) premarket notification submitted by Grieshaber & Co. for the device "GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP". The FDA issued a decision of Substantially Equivalent on April 12, 1990. The device falls under product code HQW (Clip, Tantalum, Ophthalmic), a Class II device regulated under 21 CFR 886.3100. Grieshaber & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1990
Date Received
December 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Tantalum, Ophthalmic
Device Class
Class II
Regulation Number
886.3100
Review Panel
OP
Submission Type