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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 K860105
Device Name SPIRAL-FLEX
Applicant
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Applicant Contact STEEN, PH.D.
Correspondent
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Correspondent Contact STEEN, PH.D.
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/13/1986
Decision Date 03/04/1986
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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