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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K982661
Device Name CDR - PAN MODEL 4700
Applicant
Schick Technologies, Inc.
3100 47th Ave.
Long Island,  NY  11101
Applicant Contact ENRICO RENZI
Correspondent
Schick Technologies, Inc.
3100 47th Ave.
Long Island,  NY  11101
Correspondent Contact ENRICO RENZI
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/30/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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