The following data is part of a premarket notification filed by Sedecal S.a. with the FDA for Easy Moving Plus, Sm-xxhf-yy.
Device ID | K090322 |
510k Number | K090322 |
Device Name: | EASY MOVING PLUS, SM-XXHF-YY |
Classification | System, X-ray, Mobile |
Applicant | SEDECAL S.A. 333 MILFORD ROAD Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm SEDECAL S.A. 333 MILFORD ROAD Deerfield, IL 60015 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-09 |
Decision Date | 2009-03-17 |
Summary: | summary |