BURNAID BURN FIRST AID DRESSING

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

RYE PHARMACEUTICALS PTY. LTD.

The following data is part of a premarket notification filed by Rye Pharmaceuticals Pty. Ltd. with the FDA for Burnaid Burn First Aid Dressing.

Pre-market Notification Details

Device IDK953505
510k NumberK953505
Device Name:BURNAID BURN FIRST AID DRESSING
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant RYE PHARMACEUTICALS PTY. LTD. 916 CATALPA WAY Petaluma,  CA  94954
ContactJohn C Price
CorrespondentJohn C Price
RYE PHARMACEUTICALS PTY. LTD. 916 CATALPA WAY Petaluma,  CA  94954
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-26
Decision Date1996-02-09

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