COOL RENEWAL, LLC

FDA Device Registration & Listing · Nashville, TN, US · Registration 3012697079

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
3012697079
FEI Number
3012327827
Entity Name
COOL RENEWAL, LLC
City/State/Country
Nashville, TN, US
Establishment Address
2515 Eugenia Ave Ste 103, Nashville, TN 37211, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Cool Renewal, LLC (Owner Number: 10052288)
Owner / Operator Contact Address
2515 Eugenia Ave, Suite 103, Nashville, TN 37211, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161296
PMA Number
N/A

All Registered Proprietary Names

Cool Renewal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2016-07-11

Official Correspondent

Ashley Rains

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cool Renewal, 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
K190651 Erbe Elektromedizin GmbH ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 2020-01-07
K760953 Spembly Medical , Ltd. DEEP FREEZE SYSTEM (DFS-30) 1976-11-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012697079. Last updated year: 2026. Please use registration number 3012697079 when referencing this establishment in official correspondence.
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