The following data is part of a premarket notification filed by Protege Biomedical with the FDA for Ihm Technology Bandage.
| Device ID | K180893 |
| 510k Number | K180893 |
| Device Name: | IHM Technology Bandage |
| Classification | Dressing, Wound, Drug |
| Applicant | Protege Biomedical 10909 Valley View Rd. Eden Prairie, MN 55344 |
| Contact | Mike Corcoran |
| Correspondent | Mike Corcoran Protege Biomedical 10909 Valley View Rd. Eden Prairie, MN 55344 |
| 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 | 2018-04-05 |
| Decision Date | 2018-09-19 |
| Summary: | summary |