510(k) K841548

HEMOCLIP LIGATING CLIPS M/LARGE by Edward Weck, Inc. — Product Code FZP

K841548 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "HEMOCLIP LIGATING CLIPS M/LARGE". The FDA issued a decision of Substantially Equivalent on August 14, 1984. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1984
Date Received
April 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type