PERINEOMETER
FDA 510(k) clearance K960311 · decided 1996-04-18
Clearance details
- K-number
- K960311
- Device name
- PERINEOMETER
- Applicant
- Hollister, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-22
- Decision date
- 1996-04-18
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HIR
- Device class
- 2
- Regulation number
- 884.1425
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Libertyville, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.