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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K002089
Device Name ROSETTA-LT/ROSETTA-RX
Applicant
General Devices
1000 River St.
Ridgefield,  NJ  07657
Applicant Contact MICHAEL SMITH
Correspondent
General Devices
1000 River St.
Ridgefield,  NJ  07657
Correspondent Contact MICHAEL SMITH
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/11/2000
Decision Date 11/21/2000
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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