MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057


Device Classification Name

pump, portable, aspiration (manual or powered)

510(k) Number K021368
Device Name MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
Original Applicant
MEDELA AG
laettichstrasse 4
ch-6340 baar, 

CH

Original Contact rerner frei
Regulation Number 878.4780
Classification Product Code
BTA  
Date Received 04/30/2002
Decision Date 05/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No