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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K971968
Device Name SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
Applicant
Remington Medical, Inc.
6830 Meadowridge Court
Alpharetta,  GA  30202
Applicant Contact DON ROSVOLD
Correspondent
Remington Medical, Inc.
6830 Meadowridge Court
Alpharetta,  GA  30202
Correspondent Contact DON ROSVOLD
Regulation Number870.2900
Classification Product Code
DSA  
Date Received05/28/1997
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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