THE KLINE APPLICATOR
FDA 510(k) clearance K823517 · decided 1983-01-18
Clearance details
- K-number
- K823517
- Device name
- THE KLINE APPLICATOR
- Applicant
- Kline Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-29
- Decision date
- 1983-01-18
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HGD
- Device class
- 1
- Regulation number
- 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.