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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 K932204
Device Name E-Z THERM 3 SECOND THERMOMETER
Applicant
NORTH AMERICAN TECHNICAL SERVICES CORP.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD LANZILLOTTO
Correspondent
NORTH AMERICAN TECHNICAL SERVICES CORP.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/06/1993
Decision Date 10/03/1994
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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