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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
p.o. box 68
noblesville,  IN  46060
Original Contact timothy d struthers
Regulation Number868.5975
Classification Product Code
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