The following data is part of a premarket notification filed by Macbrud Corp. Medical Div. with the FDA for Specboard.
Device ID | K891090 |
510k Number | K891090 |
Device Name: | SPECBOARD |
Classification | System, X-ray, Mammographic |
Applicant | MACBRUD CORP. MEDICAL DIV. 6280 SUNSET DRIVE #411 Miami, FL 33143 |
Contact | Lary, Md |
Correspondent | Lary, Md MACBRUD CORP. MEDICAL DIV. 6280 SUNSET DRIVE #411 Miami, FL 33143 |
Product Code | IZH |
CFR Regulation Number | 892.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-06 |
Decision Date | 1989-04-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SPECBOARD 76517170 2855725 Live/Registered |
MACBRUD CORPORATION 2003-05-28 |
![]() SPECBOARD 74097695 1706475 Dead/Cancelled |
MAC BRUD CORPORATION 1990-09-17 |