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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K894206
Device Name INTOPO
Applicant
Acacia, Inc.
P.O. Box 1240
Loma Linda,  CA  92354
Applicant Contact MARGARET LUMIA
Correspondent
Acacia, Inc.
P.O. Box 1240
Loma Linda,  CA  92354
Correspondent Contact MARGARET LUMIA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/19/1989
Decision Date 10/27/1989
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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