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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K853757
Device Name MOLDTEC STIMULATOR
Applicant
Moldtec, Inc.
906 Montegut St.
New Orleans,  LA  70117
Applicant Contact ANDREWS
Correspondent
Moldtec, Inc.
906 Montegut St.
New Orleans,  LA  70117
Correspondent Contact ANDREWS
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/09/1985
Decision Date 02/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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