ORLON NONABSORABLE SURGICAL SUTURE USP


Device Classification Name

suture, nonabsorbable, synthetic, polyamide

510(k) Number K030177
Device Name ORLON NONABSORABLE SURGICAL SUTURE USP
Original Applicant
SRI ORION PHARMACEUTICALS & SUTURES
9109 copenhaver dr.
potomac, 
MD 
20854

Original Contact norman f estrin
Regulation Number 878.5020
Classification Product Code
GAR  
Date Received 01/17/2003
Decision Date 07/21/2003
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