FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5


Device Classification Name

suture, nonabsorbable, steel, monofilament and multifilament, sterile

510(k) Number K081060
Device Name FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
Applicant
CORE ESSENCE ORTHOPAEDICS, LLC
301 oxford valley rd.
suite 905b
yardley, 
PA 
19067

Applicant Contact shawn t huxel
Correspondent
CORE ESSENCE ORTHOPAEDICS, LLC
301 oxford valley rd.
suite 905b
yardley, 
PA 
19067

Correspodent Contact shawn t huxel
Regulation Number 878.4495
Classification Product Code
GAQ  
Date Received 04/14/2008
Decision Date 12/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No