BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER


Device Classification Name

non-bronchoscopic bronchoalveolar lavage catheter

510(k) Number K112562
Device Name BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
Applicant
KIMBERLY-CLARK
1400 holcomb bridge road
roswell, 
GA 
30076

Applicant Contact david lee
Correspondent
KIMBERLY-CLARK
1400 holcomb bridge road
roswell, 
GA 
30076

Correspodent Contact david lee
Regulation Number 868.6810
Classification Product Code
OYI  
Date Received 09/26/2011
Decision Date 12/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No