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FDA 510(k)

MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION

K-Number: K904904 · 1991-03-19

ApplicantGraham-Field, Inc.
Decision Date1991-03-19
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Graham-Field, Inc.. It received FDA 510(k) clearance on 1991-03-19 under 510(k) number K904904. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION?

MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Graham-Field, Inc.. The 510(k) number is K904904.

When did MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION receive FDA 510(k) clearance?

MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION received FDA 510(k) clearance on 1991-03-19, under 510(k) number K904904.

Who is the listed applicant for MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION?

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

What is the FDA product code for MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION?

The FDA product code for MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION is KGX.

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Other records listing Graham-Field, 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.

K970035JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009K961857LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060K924876TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIEDK901947CARDISUNY 501ABK901948CARDISUNY 501BIIIK900849CARDISUNY, 501BX

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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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