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Promisemed Triple Safety Pen Needle
FDA 510(k)Class II (US FDA 510(k))
510(k) K202682
Identifiers
- 510(k) Number
- K202682 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Promisemed Triple Safety Pen Needle by Promisemed Hangzhou Meditech Co., Ltd. — Class II — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (0 countries)
Regulatory Authorizations
No authorizations listed.
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
Sources (1)
- FDA 510(k) K202682 24 fields · synced Oct 7, 2026