CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
FDA 510(k) clearance K895446 · decided 1989-11-27
Clearance details
- K-number
- K895446
- Device name
- CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
- Applicant
- Challenge Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-09-08
- Decision date
- 1989-11-27
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- HDB
- Device class
- 2
- Regulation number
- 884.4340
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bend, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.