The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Mdt Urology Table.
Device ID | K942485 |
510k Number | K942485 |
Device Name: | MDT UROLOGY TABLE |
Classification | Table, Cystometric, Electric |
Applicant | MDT CORP., INC. 1777 EAST HENRIETTA RD. Rochester, NY 14623 |
Contact | Mark N Smith |
Correspondent | Mark N Smith MDT CORP., INC. 1777 EAST HENRIETTA RD. Rochester, NY 14623 |
Product Code | MMZ |
CFR Regulation Number | 876.4890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-25 |
Decision Date | 1994-08-26 |