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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liquid Chromatography, Adsorbent
510(k) Number K832197
Device Name PRP-1 REVERSED PHASE RESIN
Applicant
Hamilton Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hamilton Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2260
Classification Product Code
DMZ  
Date Received07/07/1983
Decision Date 08/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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