510(k) K842701
K842701 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "HOPPENSTEIN MICROSURGICAL SPINAL INSTRU". The FDA issued a decision of Substantially Equivalent on Aug 2, 1984. The device falls under product code FZS (Curette, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Downs Surgical , Ltd. has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 2, 1984
- Date Received
- Jul 11, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curette, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt