510(k) K874243

ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 by Pilling Co. — Product Code GAD

K874243 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000". The FDA issued a decision of Substantially Equivalent on November 13, 1987. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Pilling Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1987
Date Received
October 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type