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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 K781140
Device Name CUTTER RESIFLEX FOLEY CATHETERS
Applicant
Cutler Laboratories, Inc.
MD 
Correspondent
Cutler Laboratories, Inc.
MD 
Regulation Number862.3610
Classification Product Code
DJC  
Date Received08/21/1978
Decision Date 09/07/1978
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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