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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
Applicant
ARTEC ENVIRONMENTAL MONITORING DIVISION
P.O. BOX 68
NOBLESVILLE,  IN  46060
Applicant Contact TIMOTHY D STRUTHERS
Correspondent
ARTEC ENVIRONMENTAL MONITORING DIVISION
P.O. BOX 68
NOBLESVILLE,  IN  46060
Correspondent 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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