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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 ROAD
SUITE B-1
BALTIMORE,  MD  21220
Applicant Contact TIMOTHY BYRD
Correspondent
POLYTECHNIC RESOURCES, INC.
1107 MIDDLE RIVER ROAD
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
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