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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K843724
Device Name I.V. START KIT & OBSTETRICAL KIT
Applicant
E.M. Adams
121 W. St.
Medfield,  MA  02052
Applicant Contact RICHARD K DONAHUE
Correspondent
E.M. Adams
121 W. St.
Medfield,  MA  02052
Correspondent Contact RICHARD K DONAHUE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/24/1984
Decision Date 01/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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