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 |