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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 K020797
Device Name PULMO-MIST COMPRESSOR MODEL # 4323
Applicant
Nidek Medical Products, Inc.
3949 Valley E. Industrial Dr.
Birmingham,  AL  35217
Applicant Contact L. G SUELTER
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact PAMLEA K GWYNN
Regulation Number868.6250
Classification Product Code
BTI  
Subsequent Product Code
CAF  
Date Received03/12/2002
Decision Date 05/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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