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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing and support, ventilator (w harness)
510(k) Number K850151
Device Name L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
Applicant
LIFE PRODUCTS, INC.
2545 CENTRAL AVE.
BOULDER,  CO  80301
Applicant Contact DOUGLAS BARNES
Correspondent
LIFE PRODUCTS, INC.
2545 CENTRAL AVE.
BOULDER,  CO  80301
Correspondent Contact DOUGLAS BARNES
Regulation Number868.5975
Classification Product Code
BZO  
Date Received01/15/1985
Decision Date 07/19/1985
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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