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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
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