510(k) K992964
- Device
- IBC VENT VALVE, MODEL 1400
- Applicant
- INTERNATIONAL BIOPHYSICS CORP.
- 510(k) number
- K992964
- Product code
- MNJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-19
- Date received
- 1999-09-02
- Regulation
- 870.4400
- Classification name
- Valve, Pressure Relief, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- H. DAVID SHOCKLET, JR
- Address
- 4020 S. Industrial Dr. Suite 160 Austin TX US 78744 78744
Source Documents#
Other 510(k) Records For Product Code MNJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K941492 | PRESSURE RELIEF VALVE | Circulatory Technology, Inc. | 1994-10-26 |
Legacy Summary#
summary
FDA Review#
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