The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Cotton Tipped Applicators, Single.
| Device ID | K843720 |
| 510k Number | K843720 |
| Device Name: | COTTON TIPPED APPLICATORS, SINGLE |
| Classification | Applicator, Absorbent Tipped, Non-sterile |
| Applicant | ABCO DEALERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KXF |
| CFR Regulation Number | 880.6025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1984-10-04 |