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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 K932119
Device Name CLEVELAND TUBING, INC. VENTILATOR HOSES
Applicant
Cleveland Tubing, Inc.
1675 Hardeman Ln.
P.O. Box 2698
Cleveland,  TN  37320
Applicant Contact ROBERT STEINBARGER
Correspondent
Cleveland Tubing, Inc.
1675 Hardeman Ln.
P.O. Box 2698
Cleveland,  TN  37320
Correspondent Contact ROBERT STEINBARGER
Regulation Number868.5975
Classification Product Code
BZO  
Date Received05/03/1993
Decision Date 06/23/1993
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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