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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, And Accessories, Dental
510(k) Number K830441
Device Name DIFF 4 SYSTEM
Applicant
Coulter Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Coulter Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4920
Classification Product Code
EKZ  
Date Received02/10/1983
Decision Date 05/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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