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 |