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FDA 510(k)

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.

K-Number: K822240 · 1982-12-30

ApplicantAmerican Mcgaw
Decision Date1982-12-30
Product CodeKFX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. is the device name listed in this FDA 510(k) record. The listed applicant is American Mcgaw. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K822240. The device is classified under product code KFX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.?

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is American Mcgaw. The 510(k) number is K822240.

When did ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. receive FDA 510(k) clearance?

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. received FDA 510(k) clearance on 1982-12-30, under 510(k) number K822240.

Who is the listed applicant for ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.?

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

What is the FDA product code for ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.?

The FDA product code for ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. is KFX.

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Other records listing American Mcgaw 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.

K853549MCGAW/DROP WATCH FLOW MONITORK843639ADD-A-VIAL SOLUTION TRANSFER DEVICEK843954MIXING CONTAINERK841729ACCUPRO ENTERAL FEEDING PUMPK840388PAB IV CONTAINERK840212CONCENTRATED PLATELET ADMIN. SET

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Related Devices (Code: KFX)

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.

K932184STERILE LEMAITRE GLOW 'N TELL TAPEVascutech, Inc.K833868IPOS G.L.P. SYSTEMIpos LuneburgK830285REGNELL HYDRAULIC FEMORAL PROTHESISBesco Financial Service

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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