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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K931348
Device Name BATTERY PACK #1005NC
Applicant
Portable Power Systems, Inc.
1940 Tee Ln.
Castle Rock,  CO  80104
Applicant Contact NORMAN PREMO
Correspondent
Portable Power Systems, Inc.
1940 Tee Ln.
Castle Rock,  CO  80104
Correspondent Contact NORMAN PREMO
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/17/1993
Decision Date 02/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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