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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Ultrasonic, Medical Instrument
510(k) Number K861590
Device Name WEC-KLEEN, CATALOG N. 850-102
Applicant
Palmetto Chemical & Supply Co., Inc.
600 Stitt St.
P.O. Box 1218
Monroe,  NC  28110
Applicant Contact D. F ADERHOLDT
Correspondent
Palmetto Chemical & Supply Co., Inc.
600 Stitt St.
P.O. Box 1218
Monroe,  NC  28110
Correspondent Contact D. F ADERHOLDT
Regulation Number880.6150
Classification Product Code
FLG  
Date Received04/29/1986
Decision Date 06/17/1986
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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