510(k) K041154
K041154 is an FDA 510(k) premarket notification submitted by Sscor for the device "S-SCORT...JR QUICKDRAW, MODEL 2400". The FDA issued a decision of Substantially Equivalent on May 18, 2004. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Sscor has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2004
- Date Received
- May 3, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type