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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Dental
510(k) Number K945727
Device Name CATCO NEONATAL PALATE GUARD
Applicant
Catco Medical, Inc.
9010 Foxland Dr.
San Antonio,  TX  78230
Applicant Contact CLYDE N BAKER
Correspondent
Catco Medical, Inc.
9010 Foxland Dr.
San Antonio,  TX  78230
Correspondent Contact CLYDE N BAKER
Regulation Number868.5820
Classification Product Code
BRW  
Date Received11/22/1994
Decision Date 12/07/1994
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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