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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K853621
Device Name REPLACEMENT PUMP TUBING
Applicant
SHABAN MFG. CO.
3052 METRO PKWY.
FORT MYERS,  FL  33901
Applicant Contact BARBARA H SNEADE
Correspondent
SHABAN MFG. CO.
3052 METRO PKWY.
FORT MYERS,  FL  33901
Correspondent Contact BARBARA H SNEADE
Regulation Number862.2160
Classification Product Code
JJE  
Date Received08/29/1985
Decision Date 12/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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