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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical
510(k) Number K874719
Device Name STRATUM ESU
Applicant
Alternative Design Systems, Inc.
419 Hackensack Ave.
Carlstadt,  NJ  07072
Applicant Contact ORLANDO, III
Correspondent
Alternative Design Systems, Inc.
419 Hackensack Ave.
Carlstadt,  NJ  07072
Correspondent Contact ORLANDO, III
Regulation Number878.4400
Classification Product Code
JOS  
Date Received11/17/1987
Decision Date 02/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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