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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K911436
Device Name SHARPS PIN CUSHION(TM) CONTAINER
Applicant
CATALYST, INC.
1256 SOUTH JACKSON ST.
FRANKFORT,  IN  46041
Applicant Contact DOUGLAS S CONARD
Correspondent
CATALYST, INC.
1256 SOUTH JACKSON ST.
FRANKFORT,  IN  46041
Correspondent Contact DOUGLAS S CONARD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/02/1991
Decision Date 07/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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