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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K833831
Device Name 3-DAY BIOINDICATOR RELEASE FOR STERIL
Applicant
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/07/1983
Decision Date 03/21/1984
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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