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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K925288
Device Name TRACHEOSTOMY KIT
Applicant
Ajs Medical Co., Inc.
300 Davisson Run Rd.
Suite 301
Clarksburg,  WV  26301
Applicant Contact JAMES D WEINSTEIN
Correspondent
Ajs Medical Co., Inc.
300 Davisson Run Rd.
Suite 301
Clarksburg,  WV  26301
Correspondent Contact JAMES D WEINSTEIN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received10/21/1992
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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