GREDALE, LLC

FDA Device Registration & Listing · Los Angeles, CA, US · Registration 3016711507

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
3016711507
FEI Number
3016711507
Entity Name
GREDALE, LLC
City/State/Country
Los Angeles, CA, US
Establishment Address
1735 S Santa Fe Avenue, Los Angeles, CA 90021, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Gredale, LLC (Owner Number: 10065040)
Owner / Operator Contact Address
1735 S Santa Fe Avenue, Los Angeles, CA 90021, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Gredale USA-Made Surgical Gown

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gredale, 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
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016711507. Last updated year: 2026. Please use registration number 3016711507 when referencing this establishment in official correspondence.
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