FDA 510(k)

BREATHABLE OVERWRAY BANDAGE NON-ELAS

K-Number: K833731 · 1984-01-27

ApplicantAmerican Medical Disposable, Inc.

Decision Date1984-01-27

Product CodeKGX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BREATHABLE OVERWRAY BANDAGE NON-ELAS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Disposable, Inc.. It received FDA 510(k) clearance on 1984-01-27 under 510(k) number K833731. 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 BREATHABLE OVERWRAY BANDAGE NON-ELAS?

BREATHABLE OVERWRAY BANDAGE NON-ELAS is a medical device that received FDA 510(k) clearance on 1984-01-27. The listed applicant is American Medical Disposable, Inc.. The 510(k) number is K833731.

When did BREATHABLE OVERWRAY BANDAGE NON-ELAS receive FDA 510(k) clearance?

BREATHABLE OVERWRAY BANDAGE NON-ELAS received FDA 510(k) clearance on 1984-01-27, under 510(k) number K833731.

Who is the listed applicant for BREATHABLE OVERWRAY BANDAGE NON-ELAS?

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

What is the FDA product code for BREATHABLE OVERWRAY BANDAGE NON-ELAS?

The FDA product code for BREATHABLE OVERWRAY BANDAGE NON-ELAS is KGX.

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Other records listing American Medical Disposable, Inc. as applicant

K833735AN ODOR ABSORBENT BANDAGE K833734NEUROLOGICAL SPONGE ON PLASTIC STICK K833730NON ADHERENT BANDAGE/SHEET K833729ELASTIC BREATHABLE OVER-WRAP BANDAGE K833733NON - ADHERENT BANDAGE K833732NON WETTING UNDERCAST PADDING

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Related Devices (Code: KGX)

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.