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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K944414
Device Name DEKALB
Applicant
ENDOTEC, INC.
6550A BEST FRIEND RD.
NORCROSS,  GA  30071
Applicant Contact FREDDIE P ANDRIENI
Correspondent
ENDOTEC, INC.
6550A BEST FRIEND RD.
NORCROSS,  GA  30071
Correspondent Contact FREDDIE P ANDRIENI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/08/1994
Decision Date 09/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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