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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K950630
Device Name WALLACH DIGITAL IMAGING SYSTEM
Applicant
Wallach Surgical Devices, Inc.
291 Pepe'S Farm Rd.
Milford,  CT  06460
Applicant Contact RAYMOND A WILEY
Correspondent
Wallach Surgical Devices, Inc.
291 Pepe'S Farm Rd.
Milford,  CT  06460
Correspondent Contact RAYMOND A WILEY
Regulation Number892.2010
Classification Product Code
LMB  
Date Received02/13/1995
Decision Date 11/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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