Promisemed Safety Huber Needles— 510(k) K251138

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K251138 for Promisemed Safety Huber Needles, Substantially Equivalent on 2025-05-13. Applicant: Promisemed Hangzhou Meditech Co., Ltd..

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code PTI
Advisory panel: General Hospital
Date received: 2025-04-14
Decision date: 2025-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Hangzhou City, CN

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