WECK REUSABLE OBTURATOR


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K121796
Device Name WECK REUSABLE OBTURATOR
Applicant
Teleflex Medical, Inc.
2917 weck dr.
research triangle park, 
NC 
27709

Applicant Contact holly kornegay
Correspondent
Teleflex Medical, Inc.
2917 weck dr.
research triangle park, 
NC 
27709

Correspodent Contact holly kornegay
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 06/19/2012
Decision Date 10/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls