Teledyne Densco Dry Tips Saliva Absorb-
FDA 510(k) K843539 · Molnlycke A/S Hospital Products
510(k) numberK843539
Submission
- Device name
- Teledyne Densco Dry Tips Saliva Absorb-
- Applicant
- Molnlycke A/S Hospital Products
Walker, MI, US - Received
- September 7, 1984
- Decision date
- May 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EFN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872810 | Strung Dental RollsEFN · Traditional | American Silk Sutures, Inc. | 12/04/1987SE |
| K871464 | Medgroup Enterprises Cotton Gauze Sponges-Non SterEFN · Traditional | Medgroup Enterprises, Inc. | 04/30/1987SE |
| K863764 | Cotton Rolls, Non-SterileEFN · Traditional | The Medical Group, Inc. | 10/27/1986SE |
| K861338 | Dental Cotton Rolls, Sterile and Non-SterileEFN · Traditional | Intl. Verbandstoff-Fabrik Schaffhau | 08/06/1986SE |
| K861727 | Cotton Filled Gauze Sponges 2 X 2EFN · Traditional | Cross Country Paper Products Corp. | 07/10/1986SE |
| K841327 | Dental Cotton RollsEFN · Traditional | Intl. Verbandstoff-Fabrik Schaffhau | 07/03/1984SE |
| K834056 | Schein Cotton Rolls, Non-SterileEFN · Traditional | Henry Schein, Inc. | 02/03/1984SE |
| K830175 | Sterile Cotton Rolls #3, 1 1/2EFN · Traditional | Veratex Corp. | 02/18/1983SE |
| K812709 | Sterile Dental RollEFN · Traditional | Medspec Corp. | 10/23/1981SE |
| K810830 | Hoyt Cotton RollsEFN · Traditional | Hoyt Laboratories | 04/14/1981SE |
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Questions and answers
When was Teledyne Densco Dry Tips Saliva Absorb- cleared by the FDA?
Teledyne Densco Dry Tips Saliva Absorb- (K843539) received a 510(k) decision of Substantially Equivalent on May 23, 1985, 258 days after the submission was received.
What is the product code of K843539?
The FDA product code is EFN – Cotton, Roll, a Class I (low risk) device regulated under 21 CFR 872.6050.