The following data is part of a premarket notification filed by C.m.a. with the FDA for Mammoloader By C.m.a. Srl.
Device ID | K973125 |
510k Number | K973125 |
Device Name: | MAMMOLOADER BY C.M.A. SRL |
Classification | Processor, Radiographic-film, Automatic |
Applicant | C.M.A. 7916 KETTLEWOOD CT. Plano, TX 75025 |
Contact | Carl Alletto |
Correspondent | Carl Alletto C.M.A. 7916 KETTLEWOOD CT. Plano, TX 75025 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-20 |
Decision Date | 1997-10-08 |
Summary: | summary |