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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
Predetermined Change
Control Plan Authorized		 No
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