510(k) K895527
K895527 is an FDA 510(k) premarket notification submitted by Quantitative Technologies, Inc. for the device "THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Quantitative Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1989
- Date Received
- September 12, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Instrument
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type