Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
FDA 510(k) K121819 · Covalontechnologies, Inc.
510(k) numberK121819
Submission
- Device name
- Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
- Applicant
- Covalontechnologies, Inc.
Mississauga, Ontario, CA - Received
- June 21, 2012
- Decision date
- August 13, 2012
- 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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| 510(k) | Device | Decision |
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| K150550 | SilverCoat Silicone Foley CatheterEZL · Traditional | 11/24/2015SE |
| K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverFRO · Traditional | 05/04/2012SE |
| K043296 | Colactive AG Collagen with Silver Antimicrobial DressingFRO · Traditional | 06/06/2005SE |
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Questions and answers
When was Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver cleared by the FDA?
Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (K121819) received a 510(k) decision of Substantially Equivalent on August 13, 2012, 53 days after the submission was received.
What is the product code of K121819?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.