510(k) K926540

SOPHER AND BIERER OVUM FORCEPS by Thomasville Medical Assoc. — Product Code HLZ

K926540 is an FDA 510(k) premarket notification submitted by Thomasville Medical Assoc. for the device "SOPHER AND BIERER OVUM FORCEPS". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Thomasville Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1994
Date Received
December 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Corneal
Device Class
Class II
Regulation Number
886.1220
Review Panel
OP
Submission Type