ISOVAC PRODUCTS LLC

FDA Device Registration & Listing · ROMEOVILLE, IL, US · Registration 3006076009

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006076009
FEI Number
3006076009
Entity Name
ISOVAC PRODUCTS LLC
City/State/Country
ROMEOVILLE, IL, US
Establishment Address
1306 Enterprise Dr Ste C, ROMEOVILLE, IL 60446, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ISOVAC PRODUCTS LLC (Owner Number: 9070989)
Owner / Operator Contact Address
1306 ENTERPRISE DR., UNIT A, Romeoville, IL 60446, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K163223
PMA Number
N/A

All Registered Proprietary Names

ORCA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LGM Chamber, Patient Isolation General Hospital Class 2 880.5450 2017-12-28

Official Correspondent

Chris Schultz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ISOVAC PRODUCTS LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006076009. Last updated year: 2026. Please use registration number 3006076009 when referencing this establishment in official correspondence.
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