The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Dental Needle (cartridge Type).
| Device ID | K870921 |
| 510k Number | K870921 |
| Device Name: | DENTAL NEEDLE (CARTRIDGE TYPE) |
| Classification | Needle, Dental |
| Applicant | CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
| Contact | Vivienne Martin |
| Correspondent | Vivienne Martin CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
| Product Code | DZM |
| CFR Regulation Number | 872.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-05 |
| Decision Date | 1987-04-03 |