Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004134970

FEI Number

3004134970

Entity Name

AMERICAN BREAST CARE LP

City/State/Country

Marietta, GA, US

Establishment Address

2150 NEWMARKET PKWY, SUITE 112, Marietta, GA 30067, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

AMERICAN BREAST CARE LP (Owner Number: 9057861)

Owner / Operator Contact Address

2150 NEWMARKET PKWY, SUITE 112, --, Marietta, GA 30067, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lymphy by ABC, Lymphedema Compression Groove Pad - Y1224 Massage Form Attach ABC Move&Massage, Arm Sleeve BREAST PROSTHESIS BREAST FORM Compression Bra ABC Compression Bra or Garment or Bandage, Flat - 519F ABC Active Multi-use Bra or Garment or Bandage - 521 ABC Compression Belt or Bandage or Wrap - 919 ABC Move Bra ONE Bra or Garment or Bandage 526 ABC Active Recovery Bra or Garment or Bandage - 520 ABC Restore Bra or Garment or Bandage - 619 ABC Compression Bra or Garment or Bandage - 519 ABC Compression Velcro-front Bra or Garment or Bandage - 119

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2026-01-26
KCZ	Prosthesis, Breast, External, Used With Adhesive	General, Plastic Surgery	Class 1	878.3800	2011-06-21
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2026-02-17
NOJ	Prosthesis, Breast, External, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2003-08-06
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2024-01-08
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2013-10-28
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2024-01-08

Official Correspondent

ROBERT HALLEY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERICAN BREAST CARE LP

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004134970. Last updated year: 2026. Please use registration number 3004134970 when referencing this establishment in official correspondence.