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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K936094
Device Name PREPARE LOCK
Applicant
Prepare, Inc.
P.O. Box 30440
Santa Barbara,  CA  93130
Applicant Contact ANGEL L ISCOVICH, M.D.
Correspondent
Prepare, Inc.
P.O. Box 30440
Santa Barbara,  CA  93130
Correspondent Contact ANGEL L ISCOVICH, M.D.
Regulation Number868.5770
Classification Product Code
CBH  
Date Received12/22/1993
Decision Date 02/03/1994
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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