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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
Predetermined Change
Control Plan Authorized		 No
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