Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183644

FEI Number

2183644

Entity Name

Lee Medical

City/State/Country

SKILLMAN, NJ, US

Establishment Address

30 VREELAND DR STE 8, SKILLMAN, NJ 08558, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TarcaLLC (Owner Number: 2183644)

Owner / Operator Contact Address

30 Vreeland Street, Suite #8, Skillman, NJ 08558, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bone Shark ® LEE-LOK NEEDLE FOR BONE MA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2011-03-30
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-12-10

Official Correspondent

Sandy Tarca

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TarcaLLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Similar Registrations

Registration Number	Establishment Name	Location
3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE
1625507	MEDTRONIC POWERED SURGICAL SOLUTIONS	FORT WORTH, TX, US
2246990	J & J INSTRUMENTS, LLC	Stratford, CT, US
1061927	INTERNATIONAL STERILIZATION LABORATORY, LLC	GROVELAND, FL, US
1834331	PARAGON MEDICAL, INC.	PIERCETON, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183644. Last updated year: 2026. Please use registration number 2183644 when referencing this establishment in official correspondence.