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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 K922009
Device Name DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
Applicant
Remington Medical, Inc.
C/O Medical Device Inspection
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
Remington Medical, Inc.
C/O Medical Device Inspection
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number870.2900
Classification Product Code
DSA  
Date Received04/29/1992
Decision Date 02/25/1993
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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