MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
FDA 510(k) clearance K944522 · decided 1995-02-24
Clearance details
- K-number
- K944522
- Device name
- MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
- Applicant
- Medical Device Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-16
- Decision date
- 1995-02-24
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- IWJ
- Device class
- 1
- Regulation number
- 892.5650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Gainsville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product Number: recall (Z-2022-2010) | Medical Device Technologies, Inc. | 2010-07-13 |