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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Processor, Radiographic-Film, Automatic, Dental
510(k) Number K900156
Device Name AP201 DENTAL X-RAY FILM PROCESSOR
Applicant
Allied Photo Products Co., Inc.
5440-A Oakbrook Pkwy.
Norcross,  GA  30093
Applicant Contact GISELLE R FREYRE
Correspondent
Allied Photo Products Co., Inc.
5440-A Oakbrook Pkwy.
Norcross,  GA  30093
Correspondent Contact GISELLE R FREYRE
Regulation Number892.1900
Classification Product Code
EGY  
Date Received01/12/1990
Decision Date 05/14/1990
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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