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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Methamphetamine
510(k) Number K781156
FOIA Releasable 510(k) K781156
Device Name DIALYSIS SYS., PDS 400 & RO 400
Applicant
Physio-Control Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Physio-Control Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3610
Classification Product Code
DJC  
Date Received07/11/1978
Decision Date 10/24/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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