The following data is part of a premarket notification filed by Aleo Bme Inc. with the FDA for Aleo Bme Liquid Bandage.
| Device ID | K171148 |
| 510k Number | K171148 |
| Device Name: | Aleo BME Liquid Bandage |
| Classification | Bandage, Liquid |
| Applicant | Aleo BME Inc. 200 Innovations Blvd, Ste. 210A State College, PA 16803 |
| Contact | Chao Liu |
| Correspondent | Leann Latham M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 Ny, NY 10018 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-19 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001423709 | K171148 | 000 |