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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K905040
Device Name ALGINATE FIBER
Applicant
Shepherd Medical Corp.
P.O. Box 4872
Alexandria,  VA  22303
Applicant Contact GEORGE R SCHERR
Correspondent
Shepherd Medical Corp.
P.O. Box 4872
Alexandria,  VA  22303
Correspondent Contact GEORGE R SCHERR
Classification Product Code
FRO  
Date Received11/06/1990
Decision Date 08/21/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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