Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015200795

FEI Number

3015200795

Entity Name

Scapa Tapes North America, LLC

City/State/Country

Knoxville, TN, US

Establishment Address

2565 Bertelkamp Lane, Knoxville, TN 37931, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Scapa Tapes North America LLC (Owner Number: 9039148)

Owner / Operator Contact Address

111 Great Pond Drive, Windsor, CT 06095, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

"Breathe Right" Nasal Strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2007-09-12
KOL	Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer	Dental	Class 1	872.3410	2020-04-17
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2020-11-12
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2020-11-12
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2020-11-12

Official Correspondent

Jason Troutman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Scapa Tapes North America LLC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2018	St. Jude Medical, Inc.	3	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Z-0459-2026	Abbott Medical	3	Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Z-2265-2024	Abbott Medical	3	Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015200795. Last updated year: 2026. Please use registration number 3015200795 when referencing this establishment in official correspondence.