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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Container, Sharps
510(k) Number K896195
Device Name NEEDLE SYRINGE DISPOSAL DEVICE
Applicant
Advanced Medical Components, Inc.
P.O. Box 10064
Lansing,  MI  48901
Applicant Contact LYNN NILES
Correspondent
Advanced Medical Components, Inc.
P.O. Box 10064
Lansing,  MI  48901
Correspondent Contact LYNN NILES
Regulation Number880.5570
Classification Product Code
MMK  
Date Received10/25/1989
Decision Date 11/27/1989
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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