The following data is part of a premarket notification filed by Alltracel Pharma Ltd. with the FDA for Seal-on Topical Hempstatic Powder Spray.
| Device ID | K010933 |
| 510k Number | K010933 |
| Device Name: | SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY |
| Classification | Dressing, Wound, Drug |
| Applicant | ALLTRACEL PHARMA LTD. 103 NOLEN LN. Chapel Hill, NC 27516 |
| Contact | Charles H Kyper |
| Correspondent | Charles H Kyper ALLTRACEL PHARMA LTD. 103 NOLEN LN. Chapel Hill, NC 27516 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-28 |
| Decision Date | 2002-01-08 |