The following data is part of a premarket notification filed by Evolution Medical Technologies Llc with the FDA for Algiseal Pad.
| Device ID | K091194 |
| 510k Number | K091194 |
| Device Name: | ALGISEAL PAD |
| Classification | Dressing, Wound, Drug |
| Applicant | EVOLUTION MEDICAL TECHNOLOGIES LLC 3439 NE SANDY BLVD. SUITE 142 Portland, OR 97232 |
| Contact | John Manning |
| Correspondent | John Manning EVOLUTION MEDICAL TECHNOLOGIES LLC 3439 NE SANDY BLVD. SUITE 142 Portland, OR 97232 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-05-18 |
| Summary: | summary |