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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 K863910
Device Name RAINCOAT
Original Applicant
ARTEC ENVIRONMENTAL MONITORING DIVISION
p.o. box 68
noblesville,  IN  46060
Original Contact timothy d struthers
Regulation Number868.5975
Classification Product Code
BZO  
Date Received10/08/1986
Decision Date 10/20/1986
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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