510(k) K802485
K802485 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "SEARLE VASCULAR LOOPS". The FDA issued a decision of Substantially Equivalent on Feb 12, 1981. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 1981
- Date Received
- Oct 10, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Surgical, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt