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FDA 510(k)

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L

K-Number: K903402 · 1990-08-22

ApplicantMedi-Source, Inc.
Decision Date1990-08-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Source, Inc.. It received FDA 510(k) clearance on 1990-08-22 under 510(k) number K903402. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L?

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L is a medical device that received FDA 510(k) clearance on 1990-08-22. The listed applicant is Medi-Source, Inc.. The 510(k) number is K903402.

When did GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L receive FDA 510(k) clearance?

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L received FDA 510(k) clearance on 1990-08-22, under 510(k) number K903402.

Who is the listed applicant for GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L?

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

What is the FDA product code for GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L?

The FDA product code for GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L is GXY.

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.

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Other records listing Medi-Source, 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.

K890565GELLHORN PESSARY 33410 VARIOUS SIZESK890566BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZESK890567BITE BLOCK #59430

Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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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