510(k) K960327

NYLON NOABSORBABLE SURGICAL SUTURES USP by R. K. Medical L. L. C. — Product Code GAR

K960327 is an FDA 510(k) premarket notification submitted by R. K. Medical L. L. C. for the device "NYLON NOABSORBABLE SURGICAL SUTURES USP". The FDA issued a decision of SN on March 4, 1996. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. R. K. Medical L. L. C. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 4, 1996
Date Received
January 24, 1996
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