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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Impression And Matrix
510(k) Number K896621
Device Name L.T.C. REPLACEMENT GASTROSTOMY TUBE
Applicant
Intl. Medical Marketing, Inc.
P.O. Box 578
Ridge,  NY  11961
Applicant Contact RAMON MONAST
Correspondent
Intl. Medical Marketing, Inc.
P.O. Box 578
Ridge,  NY  11961
Correspondent Contact RAMON MONAST
Regulation Number872.6570
Classification Product Code
KCQ  
Date Received11/21/1989
Decision Date 03/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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