The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Mdt/castle Purus Dental Unit.
| Device ID | K914697 |
| 510k Number | K914697 |
| Device Name: | MDT/CASTLE PURUS DENTAL UNIT |
| Classification | Unit, Operative Dental |
| Applicant | MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
| Contact | Mark N Smith |
| Correspondent | Mark N Smith MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1991-11-13 |