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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 K053412
Device Name FLEXISCOPE, MODELS 50MH AND 50 MHC
Applicant
Schoelly Imaging, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
Schoelly Imaging, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number878.4160
Classification Product Code
FWF  
Date Received12/07/2005
Decision Date 02/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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