The following data is part of a premarket notification filed by Human Biosciences, Inc. with the FDA for Cellusheet, Cellufil.
| Device ID | K213092 |
| 510k Number | K213092 |
| Device Name: | Cellusheet, Cellufil |
| Classification | Dressing, Wound, Collagen |
| Applicant | Human Biosciences, Inc. 940 Clopper Rd. Gaithersburg, MD 20878 |
| Contact | Jigar Patel |
| Correspondent | Jack Slovick Methodize P.O. Box 463 Nevis, MN 56467 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-09-24 |
| Decision Date | 2021-12-15 |