THE KARL STORZ HAMOU ENDOMAT
FDA 510(k) clearance K936231 · decided 1995-01-24
Clearance details
- K-number
- K936231
- Device name
- THE KARL STORZ HAMOU ENDOMAT
- Applicant
- Karl Storz Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1993-12-29
- Decision date
- 1995-01-24
- Days to decision
- 391 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.