Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2083595

FEI Number

2083595

Entity Name

SMART PRACTICE

City/State/Country

PHOENIX, AZ, US

Establishment Address

3400 EAST MCDOWELL RD., PHOENIX, AZ 85008, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SMART PRACTICE (Owner Number: 2083595)

Owner / Operator Contact Address

3400 EAST MCDOWELL RD., --, Phoenix, AZ 85008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

allergEAZE Finn Chambers Aqua Finn Chamber FLAT PATCH allergEAZE clear patchProtect

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2007-02-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2020-11-03
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2013-06-07
KJF	System, Suspension, Cell Culture	Hematology	Class 1	864.2240	2022-02-15
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-12-18
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2020-11-03
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2023-05-24
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2013-06-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-11-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SMART PRACTICE

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3003628967	SUNG LIM INDUSTRIES, CO., LTD.	Bucheon-si Gyeonggi, KR
3007616062	IRIS BEAUTY SUPPLIES INC	DOLLARD-DES-ORMEAUX Quebec, CA
3032760064	CARAN PRECISION ENGINEERING & MANUFACTURING CORP.	Brea, CA, US
3010615336	PODOPRO UK LTD	HUDDERSFIELD England, GB
3003902419	DALIAN WENJING WOODEN INDUSTRY CO., LTD.	DALIAN Liaoning, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2083595. Last updated year: 2026. Please use registration number 2083595 when referencing this establishment in official correspondence.