510(k) K895726

VESSEL OCCLUDER by Applied Medical Technologies — Product Code GDJ

K895726 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "VESSEL OCCLUDER". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Applied Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
September 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type