FDA Registration
Active
🇺🇸 United States
AMERICAN BREAST CARE LP
Reg #: 3004134970
·
FEI: 3004134970
·
Expires 2026
Products
7
Proprietary Names
13
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- AMERICAN BREAST CARE LP
- Registration Number
- 3004134970
- FEI Number
- 3004134970
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2150 NEWMARKET PKWY, SUITE 112
- City
- Marietta
- State
- GA
- ZIP
- 30067
- Country
- US
Owner / Operator
- Firm Name
- AMERICAN BREAST CARE LP
- Operator Number
- 9057861
- Address
- 2150 NEWMARKET PKWY, SUITE 112, --
- City
- Marietta
- State
- GA
- Postal Code
- 30067
- Country
- US
- Correspondent
- ROBERT - HALLEY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2026-01-26 |
| Prosthesis, Breast, External, Used With Adhesive | KCZ | Class 1 | General, Plastic Surgery | No | 2011-06-21 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2026-02-17 |
| Prosthesis, Breast, External, No Adhesive | NOJ | Class 1 | General, Plastic Surgery | No | 2003-08-06 |
| Binder, Breast | HEF | Class 1 | General Hospital | No | 2024-01-08 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2013-10-28 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2024-01-08 |
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
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device