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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 K770125
Device Name DISPOS-A-CARE THERMOMETER SHEATH
Applicant
Chesebrough-Pond'S U.S.A. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Chesebrough-Pond'S U.S.A. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2920
Classification Product Code
FLK  
Date Received01/21/1977
Decision Date 03/14/1977
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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