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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Posture, For Cardiac And Pulmonary Treatment
510(k) Number K873039
Device Name MODEL 820 TOP=TRAK
Applicant
Sierra Laboratories, Inc.
Pilot Rd.
Post Office Box 909
Carmel Valley,  CA  93924
Applicant Contact WAYNE SHANNON
Correspondent
Sierra Laboratories, Inc.
Pilot Rd.
Post Office Box 909
Carmel Valley,  CA  93924
Correspondent Contact WAYNE SHANNON
Regulation Number868.5365
Classification Product Code
BYN  
Date Received08/04/1987
Decision Date 02/11/1988
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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