FDA 510(k)

BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS

K-Number: K072068 · 2007-12-21

ApplicantBioartificial Gel Technologies (Bagtech), Inc.

Decision Date2007-12-21

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS is the device name listed in this FDA 510(k) record. The listed applicant is Bioartificial Gel Technologies (Bagtech), Inc.. It received FDA 510(k) clearance on 2007-12-21 under 510(k) number K072068. 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 BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS?

BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is Bioartificial Gel Technologies (Bagtech), Inc.. The 510(k) number is K072068.

When did BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS receive FDA 510(k) clearance?

BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS received FDA 510(k) clearance on 2007-12-21, under 510(k) number K072068.

Who is the listed applicant for BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS?

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

What is the FDA product code for BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS?

The FDA product code for BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Bioartificial Gel Technologies (Bagtech), Inc. as applicant

K080471RADIO BIOAQUACARE

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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.