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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K002095
FOIA Releasable 510(k) K002095
Device Name SNAP MODEL 6
Applicant
Snap Laboratories, LLC
3633 W. Lake Ave., Suite 406
Glenview,  IL  60025
Applicant Contact GIL RAVIV
Correspondent
Snap Laboratories, LLC
3633 W. Lake Ave., Suite 406
Glenview,  IL  60025
Correspondent Contact GIL RAVIV
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/11/2000
Decision Date 03/02/2001
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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