510(k) K791847
K791847 is an FDA 510(k) premarket notification submitted by Medical Marketing Group for the device "ASPRI-LUKE". The FDA issued a decision of Substantially Equivalent on October 2, 1979. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Medical Marketing Group has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1979
- Date Received
- September 19, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trap, Sterile Specimen
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type