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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sera, Animal And Human
510(k) Number K812383
Device Name CALF (BOVINE) SERUM - STERILE
Applicant
Dutchland Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dutchland Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.2800
Classification Product Code
KIS  
Date Received08/20/1981
Decision Date 09/08/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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