Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006306415

FEI Number

3006306415

Entity Name

ORCA PRODUCTS LLC

City/State/Country

Dothan, AL, US

Establishment Address

100 Metro Drive, Dothan, AL 36303, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ORCA Products LLC (Owner Number: 10078278)

Owner / Operator Contact Address

100 Metro Drive, Dothan, AL 36303, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060878

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
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2023-12-07
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2023-12-07
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2023-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORCA Products LLC

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
K080022	Vascular Solutions, Inc.	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	2008-12-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006306415. Last updated year: 2026. Please use registration number 3006306415 when referencing this establishment in official correspondence.