510(k) K961925

POLYESTER NONABSORBABLE SURGICAL SUTURES USP by R. K. Medical L. L. C. — Product Code GAT

K961925 is an FDA 510(k) premarket notification submitted by R. K. Medical L. L. C. for the device "POLYESTER NONABSORBABLE SURGICAL SUTURES USP". The FDA issued a decision of SN on July 29, 1996. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. R. K. Medical L. L. C. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 29, 1996
Date Received
May 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type