Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005804614

FEI Number

3005804614

Entity Name

STRATEGIC BUSINESS HOLDINGS Inc

City/State/Country

Irvine, CA, US

Establishment Address

9620 Research Dr, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

SBH Groups Inc (Owner Number: 10085286)

Owner / Operator Contact Address

120 Measure, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blue Chroma Kerrison

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTX	Rongeur	Orthopedic	Class 1	888.4540	2025-02-24

Official Correspondent

Sandya Kamjula

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SBH Groups Inc

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005804614. Last updated year: 2026. Please use registration number 3005804614 when referencing this establishment in official correspondence.