The following data is part of a premarket notification filed by Polaroid Corp. with the FDA for Polaroid Radiographic Film Processor.
Device ID | K812088 |
510k Number | K812088 |
Device Name: | POLAROID RADIOGRAPHIC FILM PROCESSOR |
Classification | Processor, Radiographic-film, Automatic |
Applicant | POLAROID CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-22 |
Decision Date | 1981-08-31 |