Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1218905

FEI Number

1218905

Entity Name

CORNING-KENNEBUNK

City/State/Country

KENNEBUNK, ME, US

Establishment Address

2 Alfred Rd, KENNEBUNK, ME 04043, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Corning Incorporated (Owner Number: 1317452)

Owner / Operator Contact Address

836 North Street, Building 300, Tewksbury, MA 01876, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Primaria flasks greater than 100 square cm surface area. PureCoat Flasks various sizes. Falcon, Costar and Corning CELLBIND cell culture flasks greater than 100 square cm surface area Synthemax Flasks sizes greater than 100 square cm surface area Falcon MultiFlasks, various styles greater than 100 square cm surface area Corning Erlenmeyer Flasks, various sizes; Corning PureCoat rLaminin-521 Cultureware; various sizes HYPERFlasks and HYPERStack vessels and accessories; various styles and sizes CellCube Systems and accessories, various styles and sizes CellSTACK Culture Chambers and accesories, various styles and sizes PureCoat Flasks various sizes Corning Closed Systems individually wrapped centrifuge tubes and accessories Falcon Individually Wrapped Round-Bottom Tubes; Corning Cryogenic vials and accessories; Containers Corning Spinner Flasks and accessories, various styles and sizes Corning Disposable Spinner Flasks Tissue Culture Dish and BioAssay Dish Custom Transwell Permeable Supports > 100 cm2; PureCoat Cell Culture Plates and Dishes, various Styles and Sizes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2002-02-15
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2012-11-12
KJD	Spinner, Flask	Hematology	Class 1	864.2240	2013-10-28
KJE	Spinner System, Cell Culture	Hematology	Class 1	864.2240	2011-10-27
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2008-02-11

Official Correspondent

Amber Aagaard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Corning Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006847360	Corning Science Mexico	Reynosa Tamaulipas, MX
1316282	CORNING-ONEONTA	ONEONTA, NY, US
3011777678	CORNING INCORPORATED	Tewksbury, MA, US
1054657	Corning Incorporated Discovery Labware	Durham, NC, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218905. Last updated year: 2026. Please use registration number 1218905 when referencing this establishment in official correspondence.