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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 K894831
Device Name PORTABLE AIR COMPRESSOR MODEL NUMBER 8125
Applicant
Equi-Tron Mfg., Inc.
4600 Witmer Industrial Estates
Niagara Falls,  NY  14305
Applicant Contact JOHN PORTER
Correspondent
Equi-Tron Mfg., Inc.
4600 Witmer Industrial Estates
Niagara Falls,  NY  14305
Correspondent Contact JOHN PORTER
Regulation Number868.6250
Classification Product Code
BTI  
Date Received07/31/1989
Decision Date 10/24/1989
Decision Substantially Equivalent (SESE)
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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