The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Cotton Tipped Point.
| Device ID | K780929 |
| 510k Number | K780929 |
| Device Name: | COTTON TIPPED POINT |
| Classification | Applicator, Absorbent Tipped, Non-sterile |
| Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXF |
| CFR Regulation Number | 880.6025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-05 |
| Decision Date | 1978-06-30 |