New York Embroidery Studio

FDA Device Registration & Listing · Brooklyn, NY, US · Registration 3007088677

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
3007088677
FEI Number
3007088677
Entity Name
New York Embroidery Studio
City/State/Country
Brooklyn, NY, US
Establishment Address
140 58th St., Building A, Suite 8N, Brooklyn, NY 11220, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NEW YORK EMBROIDERY STUDIO (Owner Number: 10073842)
Owner / Operator Contact Address
307 West 36th Street, 3rd Floor, New York City, NY 10018, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202697
PMA Number
N/A

All Registered Proprietary Names

SafeSource Direct Surgical Mask with Ties - Level 3 SafeSource Direct Surgical Mask with Ties - Level 1 SafeSource Direct Procedure Mask with Ear Loops - Level 3 SafeSource Direct Procedure Mask with Ear Loops - Level 1 Non-Reinforced Surgical Gown, L4 Poly-Reinforced Surgical Gown, L4 Surgical Face Mask (ASTM Level 3)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-12-12
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-12-12
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-11-18

Official Correspondent

MICHELLE FEINBERG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEW YORK EMBROIDERY STUDIO
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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
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 3007088677. Last updated year: 2026. Please use registration number 3007088677 when referencing this establishment in official correspondence.
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