The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Mdt/shampaine Model 4900e Surgical Table.
Device ID | K915393 |
510k Number | K915393 |
Device Name: | MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE |
Classification | Table, Operating-room, Electrical |
Applicant | MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
Contact | Mark Smith |
Correspondent | Mark Smith MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
Product Code | GDC |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-29 |
Decision Date | 1991-12-17 |