The following data is part of a premarket notification filed by Allied Photo Products Co., Inc. with the FDA for Ap201 Dental X-ray Film Processor.
Device ID | K900156 |
510k Number | K900156 |
Device Name: | AP201 DENTAL X-RAY FILM PROCESSOR |
Classification | Processor, Radiographic-film, Automatic, Dental |
Applicant | ALLIED PHOTO PRODUCTS CO., INC. 5440-A OAKBROOK PKWY. Norcross, GA 30093 |
Contact | Giselle R Freyre |
Correspondent | Giselle R Freyre ALLIED PHOTO PRODUCTS CO., INC. 5440-A OAKBROOK PKWY. Norcross, GA 30093 |
Product Code | EGY |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-12 |
Decision Date | 1990-05-14 |