The following data is part of a premarket notification filed by Macbrud Corp., Medical Division with the FDA for Specboard Jr..
| Device ID | K123414 |
| 510k Number | K123414 |
| Device Name: | SPECBOARD JR. |
| Classification | System, X-ray, Mammographic |
| Applicant | MACBRUD CORP., MEDICAL DIVISION 14021 SW 143 COURT, UNIT 6 Miami, FL 33186 |
| Contact | Todd Lary |
| Correspondent | Todd Lary MACBRUD CORP., MEDICAL DIVISION 14021 SW 143 COURT, UNIT 6 Miami, FL 33186 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2013-01-11 |
| Summary: | summary |