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Hsg Catheter Set, 5f (Rgs0947 +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K013491
Identifiers
- 510(k) Number
- K013491 FDA 510(k)
- FDA Product Code
- LKF FDA 510(k)
- Models / Variants
- Rgs0947 FDA 510(k)Hsg Catheter Set FDA 510(k)7f FDA 510(k)Model R65-948 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Hsg Catheter Set, 5f (Rgs0947 +3 more) by A & A Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS
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 | K013491 | Class II | Active |
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Manufacturer
- Manufacturer
- A & A Medical, Inc.
Sources (1)
- FDA 510(k) K013491 24 fields · synced Jun 19, 2026