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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheostomy (w/wo connector)
510(k) Number K890342
Device Name AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
Applicant
EASTMED ENTERPRISES INC.
5 PEMBURY COURT
MARLTON,  NJ  08053
Applicant Contact RATHIN PUTATUNDA
Correspondent
EASTMED ENTERPRISES INC.
5 PEMBURY COURT
MARLTON,  NJ  08053
Correspondent Contact RATHIN PUTATUNDA
Regulation Number868.5800
Classification Product Code
BTO  
Date Received01/23/1989
Decision Date 04/27/1989
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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