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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Noninvasive
510(k) Number K945978
Device Name TUBING, NONINVASIVE
Applicant
ENDOSCOPIC TECHNOLOGIES, INC.
6550A BEST FRIEND RD.
NORDCROSS,  GA  30071
Applicant Contact FREDDIE P ANDRIENI
Correspondent
ENDOSCOPIC TECHNOLOGIES, INC.
6550A BEST FRIEND RD.
NORDCROSS,  GA  30071
Correspondent Contact FREDDIE P ANDRIENI
Regulation Number880.6740
Classification Product Code
GAZ  
Date Received12/08/1994
Decision Date 01/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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