CARAPACE PELVIC EXAM TRAYS
FDA 510(k) clearance K931822 · decided 1994-03-07
Clearance details
- K-number
- K931822
- Device name
- CARAPACE PELVIC EXAM TRAYS
- Applicant
- Carapace, Inc.
- Decision
- Unknown
- Date received
- 1993-04-08
- Decision date
- 1994-03-07
- Days to decision
- 333 days
- Clearance type
- Traditional
- Product code
- MLT
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Broken Arrow, OK, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.