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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K881514
Device Name PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM
Applicant
Hall Laboratories, Inc.
5751 Richards Cir.
Shawnee,  KS  66216
Applicant Contact JOHN E HALL
Correspondent
Hall Laboratories, Inc.
5751 Richards Cir.
Shawnee,  KS  66216
Correspondent Contact JOHN E HALL
Regulation Number868.5750
Classification Product Code
BSK  
Date Received04/11/1988
Decision Date 06/16/1988
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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