FDA Registration
Active
🇺🇸 United States
Microspecialties LLC
Reg #: 1226074
·
FEI: 3002616700
·
Expires 2026
Products
14
Proprietary Names
14
Establishment Types
5
Classifications
14
Registration Details
- Registration Name
- Microspecialties LLC
- Registration Number
- 1226074
- FEI Number
- 3002616700
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 430 Smith St
- City
- Middletown
- State
- CT
- ZIP
- 06457
- Country
- US
Regulatory Submissions
- 510(k) Number
- K980510
Owner / Operator
- Firm Name
- MICROSPECIALTIES LLC
- Operator Number
- 10053719
- Address
- 430 Smith Street
- City
- Middletown
- State
- CT
- Postal Code
- 06457
- Country
- US
- Correspondent
- Steve Levesque
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2024-06-25 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2017-01-04 |
| Collagen Corneal Shield | MOE | Class 1 | Ophthalmic | No | 2018-01-12 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2017-01-06 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2017-07-31 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2022-01-14 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2022-01-14 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2019-09-04 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2018-01-12 |
| Surgical Eye Tray | PZG | Class 1 | Ophthalmic | No | 2026-06-02 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2017-01-06 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2019-09-04 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2018-01-12 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2017-01-06 |
Proprietary Names
PROPAK Injection Kit
Keratome Blade
PRO SHIELD
COMFORTEAR PUNCTUM PLUG
MICROKARE Knife
Fixator
PRO-PAKS
PRO MARKING PEN
PRO-PAKS I Trays
MK800800 (Plano-10,-20,-30,-40) Calibrated Nidek Blades MK101101 (Plano, -10,-20,-30,-40,+10,+20) Calibrated XP Blade
MICROkeratome Tubing
PRO-DRAPE
PRO EYE SHIELD
Sponge Ophthalmic Cellulose and PVA wipes Wicks , shields, drains and spears
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Device in the United States for Export Only