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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 K030917
Device Name GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
Applicant
COLLINS MEDICAL, INC.
220 WOOD RD.
BRAINTREE,  MA  02184 -2408
Applicant Contact DONALD HENTON
Correspondent
COLLINS MEDICAL, INC.
220 WOOD RD.
BRAINTREE,  MA  02184 -2408
Correspondent Contact DONALD HENTON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/24/2003
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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