ANIMUS EZSERTER INFUSION SET INSERTER


Device Classification Name

introducer, syringe needle

510(k) Number K021700
Device Name ANIMUS EZSERTER INFUSION SET INSERTER
Original Applicant
ANIMAS CORP.
590 e. lancaster ave.
frazer, 
PA 
19355

Original Contact richard michelin
Regulation Number 880.6920
Classification Product Code
KZH  
Date Received 05/23/2002
Decision Date 06/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No