510(k) K843371
K843371 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "VALVOTOMY KNIFE". The FDA issued a decision of Substantially Equivalent on October 25, 1984. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 1984
- Date Received
- August 28, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Knife, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type