510(k) K830219
K830219 is an FDA 510(k) premarket notification submitted by Ascep, Inc. for the device "VARIOUS INSTRUMENTS & INSTRUMENT TRAYS". The FDA issued a decision of Substantially Equivalent on Apr 12, 1983. 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
- Apr 12, 1983
- Date Received
- Jan 24, 1983
- 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