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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clinical Sample Concentrator
510(k) Number K770398
Device Name MINICON
Applicant
Amicon, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Amicon, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2310
Classification Product Code
JJH  
Date Received03/02/1977
Decision Date 04/06/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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