510(k) K904906

SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP by Chathamborough Research Group, Inc. — Product Code GAW

K904906 is an FDA 510(k) premarket notification submitted by Chathamborough Research Group, Inc. for the device "SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP". The FDA issued a decision of Substantially Equivalent on December 24, 1990. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Chathamborough Research Group, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1990
Date Received
October 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type