Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183576

FEI Number

2183576

Entity Name

SMI DIV. OF SOHN MFG., INC.

City/State/Country

ELKHART LAKE, WI, US

Establishment Address

544 Sohn Dr, ELKHART LAKE, WI 53020, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SMI DIV. OF SOHN MFG., INC. (Owner Number: 2183576)

Owner / Operator Contact Address

544 SOHN DR., --, Elkhart Lake, WI 53020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-12-26

Official Correspondent

Melissa Scharrer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SMI DIV. OF SOHN MFG., 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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183576. Last updated year: 2026. Please use registration number 2183576 when referencing this establishment in official correspondence.