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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K892121
Device Name SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
Applicant
Biocom Intl., Inc.
12201 133rd Ave. E.
Puyallup,  WA  98374
Applicant Contact DENNIS W WASSMAN
Correspondent
Biocom Intl., Inc.
12201 133rd Ave. E.
Puyallup,  WA  98374
Correspondent Contact DENNIS W WASSMAN
Regulation Number868.1880
Classification Product Code
BZC  
Date Received03/31/1989
Decision Date 06/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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