SAFETOUCH
FDA 510(k) clearance K022861 · decided 2002-11-26
Clearance details
- K-number
- K022861
- Device name
- SAFETOUCH
- Applicant
- Rusin Medical Devices
- Decision
- Substantially Equivalent
- Date received
- 2002-08-28
- Decision date
- 2002-11-26
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NHM
- Device class
- 2
- Regulation number
- 884.2990
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Anoka, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAFETOUCH (K014300) | James D Rusin MD, MBA | 2002-03-01 |
Recalls involving this device
No recalls on record reference this clearance.