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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 K896798
Device Name TRACHEOSTOMY TRAY
Applicant
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Applicant Contact SURY SHONEY
Correspondent
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Correspondent Contact SURY SHONEY
Regulation Number868.5800
Classification Product Code
BTO  
Date Received12/01/1989
Decision Date 02/22/1990
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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