510(k) K844836

HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER by Edward Weck, Inc. — Product Code GWD

K844836 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER". The FDA issued a decision of Substantially Equivalent on January 23, 1985. The device falls under product code GWD (Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp), a Class II device regulated under 21 CFR 866.3220. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1985
Date Received
December 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Device Class
Class II
Regulation Number
866.3220
Review Panel
MI
Submission Type