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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K952765
Device Name DELWA-STAR PACIFIER THERMOMETER
Applicant
Zewa, Inc.
Mcdermott, Will & Emery
1850 K St., NW, Suite 500
Washington,  DC  20006
Applicant Contact DAVID L ROSEN
Correspondent
Zewa, Inc.
Mcdermott, Will & Emery
1850 K St., NW, Suite 500
Washington,  DC  20006
Correspondent Contact DAVID L ROSEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/04/1995
Decision Date 10/13/1995
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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