INFLAT-O-BALL
FDA 510(k) clearance K904026 · decided 1990-10-10
Clearance details
- K-number
- K904026
- Device name
- INFLAT-O-BALL
- Applicant
- Milex Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-30
- Decision date
- 1990-10-10
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HHW
- Device class
- 2
- Regulation number
- 884.3575
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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