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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K962070
Device Name YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
Applicant
YELLOW SPRINGS INSTRUMENT CO., INC.
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387
Applicant Contact JAMES R GRAVER
Correspondent
YELLOW SPRINGS INSTRUMENT CO., INC.
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387
Correspondent Contact JAMES R GRAVER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/28/1996
Decision Date 07/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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