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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K926269
Device Name PROCEDURE KIT
Applicant
General Medical Co.
8741 Landmark Rd.
P.O. Box 27452
Richmond,  VA  23261
Applicant Contact ALFRED H GREBE
Correspondent
General Medical Co.
8741 Landmark Rd.
P.O. Box 27452
Richmond,  VA  23261
Correspondent Contact ALFRED H GREBE
Regulation Number878.4370
Classification Product Code
LRO  
Subsequent Product Code
FMF  
Date Received12/18/1992
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
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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