510(k) K821921
K821921 is an FDA 510(k) premarket notification submitted by Emerson-Sack-Warner Corp. for the device "STAND, SURG. INSTRUMENT & DRESSING". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code FSH (Tray, Surgical, Needle), a Class I device regulated under 21 CFR 878.4800. Emerson-Sack-Warner Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1982
- Date Received
- June 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Needle
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type