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 |