MEDELA THOPAZ, MODEL 200 0288


Device Classification Name

pump, portable, aspiration (manual or powered)

510(k) Number K080212
Device Name MEDELA THOPAZ, MODEL 200 0288
Applicant
MEDELA AG
laettichstrasse 4b
baar, zug, 

CH

ch-6341

Applicant Contact bruno gretler
Correspondent
MEDELA AG
laettichstrasse 4b
baar, zug, 

CH

ch-6341

Correspodent Contact bruno gretler
Regulation Number 878.4780
Classification Product Code
BTA  
Date Received 01/29/2008
Decision Date 07/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No