510(k) K821358
K821358 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "MODIFIED RONGEURS FOR SPINAL & ORTH. S.". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code EMH (Forceps, Rongeur, Surgical), a Class I device regulated under 21 CFR 872.4565. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1982
- Date Received
- May 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Rongeur, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type