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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 K942779
Device Name DISPOSABLE BACTERIOLOGICAL FILTER
Applicant
VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Applicant Contact PHIL HEMES
Correspondent
VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Correspondent Contact PHIL HEMES
Regulation Number868.1840
Classification Product Code
BZG  
Date Received06/13/1994
Decision Date 07/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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