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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K892705
Device Name EBS2605 INFANT HUGGER
Applicant
EQUILIBRATED BIO SYSTEMS, INC.
900 WALT WHITMAN RD.
MELVILLE,  NY  11747
Applicant Contact ALEX STENZLER
Correspondent
EQUILIBRATED BIO SYSTEMS, INC.
900 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact ALEX STENZLER
Regulation Number868.1890
Classification Product Code
BTY  
Date Received04/14/1989
Decision Date 10/27/1989
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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