510(k) K903177

ADVANCE SUTURE NONABSORBABLE NYLON SUTURE by Advance Suture, Inc. — Product Code GAR

K903177 is an FDA 510(k) premarket notification submitted by Advance Suture, Inc. for the device "ADVANCE SUTURE NONABSORBABLE NYLON SUTURE". The FDA issued a decision of Substantially Equivalent on June 28, 1991. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Advance Suture, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1991
Date Received
July 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type