The following data is part of a premarket notification filed by Mdt Technology For Life with the FDA for Mdt Shampaine 5100b And 5100e Surgical Tables.
| Device ID | K941150 |
| 510k Number | K941150 |
| Device Name: | MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | MDT TECHNOLOGY FOR LIFE 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 -3077 |
| Contact | Mark N Smith |
| Correspondent | Mark N Smith MDT TECHNOLOGY FOR LIFE 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 -3077 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-10 |
| Decision Date | 1994-06-10 |