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FDA 510(k)

SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER

K-Number: K121819 · 2012-08-13

ApplicantCovalontechnologies, Inc.
Decision Date2012-08-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER is the device name listed in this FDA 510(k) record. The listed applicant is Covalontechnologies, Inc.. It received FDA 510(k) clearance on 2012-08-13 under 510(k) number K121819. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER?

SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER is a medical device that received FDA 510(k) clearance on 2012-08-13. The listed applicant is Covalontechnologies, Inc.. The 510(k) number is K121819.

When did SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER receive FDA 510(k) clearance?

SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER received FDA 510(k) clearance on 2012-08-13, under 510(k) number K121819.

Who is the listed applicant for SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER?

The FDA 510(k) record lists Covalontechnologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER?

The FDA product code for SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER is FRO. This falls under the Anesthesiology category.

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Other records listing Covalontechnologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163556MediClear PreOpK112549IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERK043296COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSINGK050177COLACTIVE COLLAGEN WOUND DRESSING

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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