The following data is part of a premarket notification filed by Molnlycke A/s Hospital Products with the FDA for Teledyne Densco Dry Tips Saliva Absorb-.
| Device ID | K843539 |
| 510k Number | K843539 |
| Device Name: | TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- |
| Classification | Cotton, Roll |
| Applicant | MOLNLYCKE A/S HOSPITAL PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EFN |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1985-05-23 |