HYALURONIDASE SOLUTION

Media, Reproductive

IRVINE SCIENTIFIC SALES CO., INC.

The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Hyaluronidase Solution.

Pre-market Notification Details

Device IDK022931
510k NumberK022931
Device Name:HYALURONIDASE SOLUTION
ClassificationMedia, Reproductive
Applicant IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana,  CA  92705
ContactWendell Lee
CorrespondentWendell Lee
IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana,  CA  92705
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-04
Decision Date2002-11-04
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.