510(k) K912355
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1993
- Date Received
- May 28, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Breast, Non-Powered
- Device Class
- Class I
- Regulation Number
- 884.5150
- Review Panel
- OB
- Submission Type