Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004361444

FEI Number

3004361444

Entity Name

GROMAN INC.

City/State/Country

Coconut Creek, FL, US

Establishment Address

2000 Banks Rd Ste G1, Coconut Creek, FL 33063, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

GROMAN INC. (Owner Number: 9054890)

Owner / Operator Contact Address

4900 NW 15TH ST., STE 4494, --, Pompano Beach, FL 33063, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SafetyO2 Standard Jet Nebulizer for SafetyNeb SafetyFilta PrepMaster EtchMaster ProphyMaster PowderMaster SafetyFilta CircuitGlow SafetyNeb

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2021-05-12
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2021-05-12
KOJ	Airbrush	Dental	Class 2	872.6080	2007-12-04
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2023-01-17
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2020-01-27
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2021-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GROMAN INC.

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
K940776	Kreativ, Inc.	KREATIV MODEL KV-1	1994-12-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004361444. Last updated year: 2026. Please use registration number 3004361444 when referencing this establishment in official correspondence.