DISPOSABLE HEATING TUBING SET #7642HSES
FDA 510(k) clearance K990662 · decided 1999-09-24
Clearance details
- K-number
- K990662
- Device name
- DISPOSABLE HEATING TUBING SET #7642HSES
- Applicant
- Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
- Decision
- Substantially Equivalent
- Date received
- 1999-03-01
- Decision date
- 1999-09-24
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Sauerlach, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.