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FDA 510(k)

INCARE HOT/ICE ABSORBENT INTERFACE

K-Number: K913035 · 1991-09-25

ApplicantHollister, Inc.
Decision Date1991-09-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

INCARE HOT/ICE ABSORBENT INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K913035. 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 INCARE HOT/ICE ABSORBENT INTERFACE?

INCARE HOT/ICE ABSORBENT INTERFACE is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Hollister, Inc.. The 510(k) number is K913035.

When did INCARE HOT/ICE ABSORBENT INTERFACE receive FDA 510(k) clearance?

INCARE HOT/ICE ABSORBENT INTERFACE received FDA 510(k) clearance on 1991-09-25, under 510(k) number K913035.

Who is the listed applicant for INCARE HOT/ICE ABSORBENT INTERFACE?

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

What is the FDA product code for INCARE HOT/ICE ABSORBENT INTERFACE?

The FDA product code for INCARE HOT/ICE ABSORBENT INTERFACE is FRO. This falls under the Anesthesiology category.

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Other records listing Hollister, Inc. as applicant

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Official Source

View on FDA Database →

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

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