510(k) K223612
- Device
- Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
- Applicant
- Ranfac Corporation
- 510(k) number
- K223612
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-21
- Date received
- 2022-12-05
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Eric Kreuz
- Address
- 30 Doherty Ave. Avon MA US 02322 02322
FDA Registration Numbers
- 1423662
- 1450662
- 3006788678
- 1825146
- 3038356900
- 3007200016
- 3022977243
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- 3015980719
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- 3007185216
- 3010381606
- 3013462478
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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