CSA Medical

FDA Device Registration & Listing · Lexington, MA, US · Registration 3010140265

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
3010140265
FEI Number
3010140265
Entity Name
CSA Medical
City/State/Country
Lexington, MA, US
Establishment Address
131 Hartwell Ave, Lexington, MA 02421, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
CSA MEDICAL, INC. (Owner Number: 9062377)
Owner / Operator Contact Address
131 Hartwell Ave, Lexington, MA 02421, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RejuvenAir

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 2020-12-22

Official Correspondent

Heather Nigro

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CSA MEDICAL, INC.
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 3010140265. Last updated year: 2026. Please use registration number 3010140265 when referencing this establishment in official correspondence.
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