510(k) K881741

STUART LEE CLIP by Stuart-Lee, Inc. — Product Code GDJ

K881741 is an FDA 510(k) premarket notification submitted by Stuart-Lee, Inc. for the device "STUART LEE CLIP". The FDA issued a decision of Substantially Equivalent on June 3, 1988. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1988
Date Received
April 22, 1988
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