510(k) DEN170064
- Device
- Comaneci, Comaneci Petit, Comaneci 17
- Applicant
- Rapid-Medical , Ltd.
- 510(k) number
- DEN170064
- Product code
- PUU
- Decision
- Unknown (DENG)
- Decision date
- 2019-04-24
- Date received
- 2017-09-28
- Regulation
- 882.5955
- Classification name
- Temporary Coil Embolization Assist Device
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Orit Yaniv
- Address
- Carmel Bldg. Pob 337 Yokneam IL 2069205 2069205
FDA Registration Numbers#
- 3015531723
- 3009957947
Source Documents#
510(k) summary PDF not indicated by FDA