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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name compressor, air, portable
510(k) Number K841537
Device Name IMPACT MODEL 601
Applicant
IMPACT INSTRUMENTATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMPACT INSTRUMENTATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.6250
Classification Product Code
BTI  
Date Received04/16/1984
Decision Date 05/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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