510(k) K030351

STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE by Cp Medical — Product Code GAQ

K030351 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE". The FDA issued a decision of Substantially Equivalent on March 28, 2003. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Cp Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2003
Date Received
February 3, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type