The following data is part of a premarket notification filed by Imation Corp. with the FDA for 3m Trimatic Modular Advanced Processing System And 3m Aps Automatic Film Processor.
Device ID | K962750 |
510k Number | K962750 |
Device Name: | 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR |
Classification | Processor, Radiographic-film, Automatic |
Applicant | IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
Contact | Stephen G Slavens |
Correspondent | Stephen G Slavens IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-15 |
Decision Date | 1996-08-21 |
Summary: | summary |