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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K823115
Device Name NATURALYTE BICARBONATE DIALYSATE 4400
Applicant
Erika, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Erika, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3510
Classification Product Code
KRO  
Date Received10/21/1982
Decision Date 12/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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