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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 K992743
Device Name COLLINS CPL
Applicant
COLLINS MEDICAL, INC.
220 WOOD RD.
BRAINTREE,  MA  02184 -2408
Applicant Contact DALE F HUBBARD
Correspondent
COLLINS MEDICAL, INC.
220 WOOD RD.
BRAINTREE,  MA  02184 -2408
Correspondent Contact DALE F HUBBARD
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/16/1999
Decision Date 09/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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