The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Prophylaxis Pack.
| Device ID | K950773 |
| 510k Number | K950773 |
| Device Name: | PROPHYLAXIS PACK |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| Contact | Steven W Butler |
| Correspondent | Steven W Butler TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-03-31 |