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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K881451
Device Name SIMPLEX UNIVERSAL HEATED TUBING SLEEVE
Applicant
Simplex Medical Corp.
8920 Limonite, Suite 291
Riverside,  CA  92509
Applicant Contact STILES III
Correspondent
Simplex Medical Corp.
8920 Limonite, Suite 291
Riverside,  CA  92509
Correspondent Contact STILES III
Regulation Number868.5270
Classification Product Code
BZE  
Date Received04/06/1988
Decision Date 06/10/1988
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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