Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1215709

FEI Number

1215709

Entity Name

ABCORP

City/State/Country

Boston, MA, US

Establishment Address

225 Rivermoor St, Boston, MA 02132, US

Establishment Type(s)

Remanufacture Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ABCorp 3D (Owner Number: 10083679)

Owner / Operator Contact Address

225 Rivermoor St, Boston, MA 02132, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2024-11-19
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2024-11-19
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2023-12-28
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2023-12-28
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2021-12-10

Official Correspondent

Neil Glazebrook Glazebrook

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABCorp 3D

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042028951	ABCORP 3D	Columbia, TN, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1215709. Last updated year: 2026. Please use registration number 1215709 when referencing this establishment in official correspondence.