510(k) K790990

REYNOLDS DOUBLE HEMOCLIP APPLIERS by Edward Weck, Inc. — Product Code GDO

K790990 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "REYNOLDS DOUBLE HEMOCLIP APPLIERS". The FDA issued a decision of Substantially Equivalent on June 5, 1979. The device falls under product code GDO (Applier, Surgical, Clip), a Class I device regulated under 21 CFR 878.4800. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1979
Date Received
May 30, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Surgical, Clip
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type