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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Endoscopic, Without Audio
510(k) Number K982397
Device Name VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
Applicant
Angiolaz, Inc.
Industrial Park
Bellows Falls,  VT  05101 -0556
Applicant Contact JOHN D PLUMADORE
Correspondent
Angiolaz, Inc.
Industrial Park
Bellows Falls,  VT  05101 -0556
Correspondent Contact JOHN D PLUMADORE
Regulation Number878.4160
Classification Product Code
FWF  
Date Received07/09/1998
Decision Date 09/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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