QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE


Device Classification Name

suture, surgical, absorbable, polydioxanone

510(k) Number K080680
Device Name QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
Applicant
SURGICAL SPECIALTIES CORP.
13921 park center rd.
suite 200
herndon, 
VA 
20171

Applicant Contact trudy d estridge
Correspondent
SURGICAL SPECIALTIES CORP.
13921 park center rd.
suite 200
herndon, 
VA 
20171

Correspodent Contact trudy d estridge
Regulation Number 878.4840
Classification Product Code
NEW  
Date Received 03/10/2008
Decision Date 03/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No