ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K112456
Device Name ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
Applicant
Teleflex Medical, Inc.
2917 weck dr.
research triangle park, 
NC 
27709

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

Correspodent Contact natalie smith
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 08/25/2011
Decision Date 10/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls