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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K953458
Device Name RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
Applicant
Raiinbow Step UP Systems, Inc.
555 Tpke. St.
North Andover,  MA  01845
Applicant Contact MELISSA A THOMPSON
Correspondent
Raiinbow Step UP Systems, Inc.
555 Tpke. St.
North Andover,  MA  01845
Correspondent Contact MELISSA A THOMPSON
Regulation Number868.1860
Classification Product Code
BZH  
Date Received07/21/1995
Decision Date 11/17/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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