The following data is part of a premarket notification filed by Shepherd Medical Corp. with the FDA for Alginate Fiber.
| Device ID | K905040 |
| 510k Number | K905040 |
| Device Name: | ALGINATE FIBER |
| Classification | Dressing, Wound, Drug |
| Applicant | SHEPHERD MEDICAL CORP. P.O. BOX 4872 Alexandria, VA 22303 |
| Contact | George R Scherr |
| Correspondent | George R Scherr SHEPHERD MEDICAL CORP. P.O. BOX 4872 Alexandria, VA 22303 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-06 |
| Decision Date | 1991-08-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALGINATE FIBER 85436886 not registered Dead/Abandoned |
GHP Biotec, LLC 2011-09-30 |