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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K042758
Device Name POLYTECH PULMONARY FUNCTION FILTER
Applicant
Polytechnic Resources, Inc.
1107 Middle River Rd.
Suite B-1
Baltimore,  MD  21220
Applicant Contact TIMOTHY BYRD
Correspondent
Polytechnic Resources, Inc.
1107 Middle River Rd.
Suite B-1
Baltimore,  MD  21220
Correspondent Contact TIMOTHY BYRD
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/04/2004
Decision Date 08/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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