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FDA 510(k)

SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS

K-Number: K083133 · 2009-10-30

ApplicantAndover Healthcare, Inc.
Decision Date2009-10-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS is the device name listed in this FDA 510(k) record. The listed applicant is Andover Healthcare, Inc.. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K083133. 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 SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS?

SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Andover Healthcare, Inc.. The 510(k) number is K083133.

When did SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS receive FDA 510(k) clearance?

SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS received FDA 510(k) clearance on 2009-10-30, under 510(k) number K083133.

Who is the listed applicant for SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS?

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

What is the FDA product code for SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS?

The FDA product code for SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS is FRO. This falls under the Anesthesiology category.

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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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