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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 K925674
Device Name BATTERY PACK #1014NC
Applicant
Portable Power Systems, Inc.
10336 S. Dransfeldt Rd.
Parker,  CO  80134
Applicant Contact NORMAN A PREMO
Correspondent
Portable Power Systems, Inc.
10336 S. Dransfeldt Rd.
Parker,  CO  80134
Correspondent Contact NORMAN A PREMO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/10/1992
Decision Date 05/26/1993
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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