510(k) K964488
- Device
- DETACHABLE SILICONE BALLOON (DSB)
- Applicant
- TARGET THERAPEUTICS
- 510(k) number
- K964488
- Product code
- MZQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-21
- Date received
- 1996-11-08
- Regulation
- 882.5950
- Classification name
- Balloon, Detachable, For Neurovascular Occlusion
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN K BELL
- Address
- 47201 Lakeview Dr. Freemont CA US 94538 94538
Source Documents#
Other 510(k) Records For Product Code MZQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K965071 | DETACHABLE SLICONE BALLOON (DSB) | Target Therapeutics | 1998-04-21 |
Legacy Summary#
summary
FDA Review#
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