S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
FDA 510(k) clearance K960640 · decided 1997-02-14
Clearance details
- K-number
- K960640
- Device name
- S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
- Applicant
- Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
- Decision
- Substantially Equivalent
- Date received
- 1996-02-12
- Decision date
- 1997-02-14
- Days to decision
- 368 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.