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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Transfer (Blood/Plasma)
510(k) Number K802940
Device Name SUPER-SPIKE TRANSFER SET
Applicant
GENEVA LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GENEVA LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.9875
Classification Product Code
KSB  
Date Received11/19/1980
Decision Date 01/15/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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