Kendall Kerlix Antimicrobial Super Sponge Dressing for OTC Use, Model 6662
FDA 510(k) K070653 · Tyco Healthcare
510(k) numberK070653
Submission
- Device name
- Kendall Kerlix Antimicrobial Super Sponge Dressing for OTC Use, Model 6662
- Applicant
- Tyco Healthcare
Mansfield, MA, US - Received
- March 9, 2007
- Decision date
- September 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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| K042709 | Dover Silver Temperature Sensing Foley CatheterEZL · Traditional | 01/18/2005SE |
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| K041243 | Dover Red Rubber Robinson CatheterKOD · Traditional | 07/07/2004SE |
| K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…NGT · Traditional | 06/30/2004SE |
| K033453 | Kendall Ultec Pro Ag+ Hydrocolloid DressingFRO · Traditional | 04/29/2004SE |
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Questions and answers
When was Kendall Kerlix Antimicrobial Super Sponge Dressing for OTC Use, Model 6662 cleared by the FDA?
Kendall Kerlix Antimicrobial Super Sponge Dressing for OTC Use, Model 6662 (K070653) received a 510(k) decision of Substantially Equivalent on September 12, 2007, 187 days after the submission was received.
What is the product code of K070653?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.