510(k) K944552

PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP by Pilling Weck, Inc. — Product Code FZP

K944552 is an FDA 510(k) premarket notification submitted by Pilling Weck, Inc. for the device "PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP". The FDA issued a decision of Substantially Equivalent on November 7, 1994. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Pilling Weck, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1994
Date Received
September 16, 1994
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