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Hybrid personal lubricant (water&silicone) (5ml +18 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K252935
Identifiers
- 510(k) Number
- K252935 FDA 510(k)
- FDA Product Code
- NUC FDA 510(k)
- Models / Variants
- 5ml FDA 510(k)8ml FDA 510(k)10ml FDA 510(k)12ml FDA 510(k)15ml FDA 510(k)20ml FDA 510(k)30ml FDA 510(k)50ml FDA 510(k)60ml FDA 510(k)75ml FDA 510(k)90ml FDA 510(k)100ml FDA 510(k)120ml FDA 510(k)150ml FDA 510(k)180ml FDA 510(k)200ml FDA 510(k)250ml FDA 510(k)300ml FDA 510(k)500ml FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5300 FDA 510(k)
- Regulation Number
- 884.5300 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Hybrid personal lubricant (water&silicone) (5ml +18 more) by Foshan Pingchuang Medical Technology Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 19…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252935 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan Pingchuang Medical Technology Co., Ltd
- FDA Applicant
- Foshan Pingchuang Medical Technology Co., Ltd.
Sources (1)
- FDA 510(k) K252935 24 fields · synced Jun 19, 2026