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FDA 510(k)

ICAN GT DRAINAGE BAG

K-Number: K914530 · 1991-12-18

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1991-12-18
Product CodeFRQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ICAN GT DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K914530. The device is classified under product code FRQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICAN GT DRAINAGE BAG?

ICAN GT DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K914530.

When did ICAN GT DRAINAGE BAG receive FDA 510(k) clearance?

ICAN GT DRAINAGE BAG received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914530.

Who is the listed applicant for ICAN GT DRAINAGE BAG?

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

What is the FDA product code for ICAN GT DRAINAGE BAG?

The FDA product code for ICAN GT DRAINAGE BAG is FRQ.

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Other records listing Icn Pharmaceuticals, 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.

K022817COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-IIK951329IMMUCHEM GAL-MW EAK914082SUAN FLAT DISSECTOR SPONGESK914086ICAN CYLINDRICAL SPONGESK914081ICAN COTTON RAYON BALLSK914083ICAN K DISSECTOR SPONGES

View all 30 devices →

Related Devices (Code: FRQ)

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.

K914887ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCTMallinckrodt MedicalK802007PEDIWET=GUAZE IMPREGNATED WITH PETROLPollak (Intl.), Ltd.

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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