The following data is part of a premarket notification filed by All-pro Imaging Corp. with the FDA for All-pro 2010.
Device ID | K001321 |
510k Number | K001321 |
Device Name: | ALL-PRO 2010 |
Classification | Processor, Radiographic-film, Automatic |
Applicant | ALL-PRO IMAGING CORP. 70 CANTIAGUE ROCK RD. P.O. BOX 870 Hicksville, NY 11801 |
Contact | Joseph Carey |
Correspondent | Joseph Carey ALL-PRO IMAGING CORP. 70 CANTIAGUE ROCK RD. P.O. BOX 870 Hicksville, NY 11801 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-26 |
Decision Date | 2000-05-16 |