510(k) K921611
K921611 is an FDA 510(k) premarket notification submitted by Mada Medical Products, Inc. for the device "MADAVAC 190". The FDA issued a decision of Substantially Equivalent on September 9, 1992. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Mada Medical Products, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1992
- Date Received
- April 3, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type