REGENESIS MODEL 42
FDA 510(k) clearance K972093 · decided 1997-10-21
Clearance details
- K-number
- K972093
- Device name
- REGENESIS MODEL 42
- Applicant
- Regenesis Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-04
- Decision date
- 1997-10-21
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- ILX
- Device class
- 2
- Regulation number
- 890.5290
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
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|---|---|---|
| Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy recall (Z-0887-2009) | Regenesis Biomedical Inc | 2009-01-26 |