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FDA 510(k)

MASCOT LAB SPONGE

K-Number: K894984 · 1989-09-05

ApplicantMascot, Inc.
Decision Date1989-09-05
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASCOT LAB SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Mascot, Inc.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894984. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASCOT LAB SPONGE?

MASCOT LAB SPONGE is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Mascot, Inc.. The 510(k) number is K894984.

When did MASCOT LAB SPONGE receive FDA 510(k) clearance?

MASCOT LAB SPONGE received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894984.

Who is the listed applicant for MASCOT LAB SPONGE?

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

What is the FDA product code for MASCOT LAB SPONGE?

The FDA product code for MASCOT LAB SPONGE is GDY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mascot, 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.

K903500MASCOT THERMOTERK894587MASCOT EXAMINATION GLOVESK894436MASCOT O.R. TOWEL

Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical Perspectives Corp.

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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