The following data is part of a premarket notification filed by Medipurpose Pte. Ltd. with the FDA for Mediplus-foam Ag; Mediplus-comfortfoam Ag; Mediplus-superfoam Ag.
Device ID | K110062 |
510k Number | K110062 |
Device Name: | MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG |
Classification | Dressing, Wound, Drug |
Applicant | MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
Contact | Julie Stephens |
Correspondent | Julie Stephens MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2011-01-10 |
Decision Date | 2011-09-01 |
Summary: | summary |