510(k) K072334
- Device
- SIALO DRAIN
- Applicant
- SIALO TECHNOLOGY, LTD.
- 510(k) number
- K072334
- Product code
- OAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-18
- Date received
- 2007-08-20
- Regulation
- 878.4200
- Classification name
- Catheter, Drainage, Intraoral/extraoral
- Medical specialty
- General & Plastic Surgery
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- AHAVA STEIN
- Address
- 20 Hata'As St. Kfar Saba IL 44425 44425
FDA Registration Numbers#
- 1064858
- 8040278
- 3006787036
- 3015489752
- 3008808560
- 3009171220
- 1220850
- 3013496867
- 3010202439
Source Documents#
Legacy Summary#
summary
FDA Review#
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