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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K893602
Device Name GLASS MERCURY FILLED THERMOMETERS
Applicant
Smith & Nephew United, Inc.
11775 Starkley Rd.
P.O.Box 1970
Largo,  FL  34649
Applicant Contact JIM IRVIN
Correspondent
Smith & Nephew United, Inc.
11775 Starkley Rd.
P.O.Box 1970
Largo,  FL  34649
Correspondent Contact JIM IRVIN
Regulation Number880.2920
Classification Product Code
FLK  
Date Received05/15/1989
Decision Date 08/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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