510(k) K810004
K810004 is an FDA 510(k) premarket notification submitted by Ascep, Inc. for the device "STERILE DISPOSABLE INSTRUMENT TRAYS". The FDA issued a decision of Substantially Equivalent on Jan 26, 1981. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Ascep, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 1981
- Date Received
- Jan 6, 1981
- 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
- 510(k) Exempt