HYALURONIDASE SOLUTION


Device Classification Name

media, reproductive

510(k) Number K022931
Device Name HYALURONIDASE SOLUTION
Original Applicant
IRVINE SCIENTIFIC SALES CO., INC.
2511 daimler st.
santa ana, 
CA 
92705

Original Contact wendell lee
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 09/04/2002
Decision Date 11/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No