510(k) K862696
K862696 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP". The FDA issued a decision of Substantially Equivalent on July 30, 1986. The device falls under product code HBT (Applier, Hemostatic Clip), 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
- July 30, 1986
- Date Received
- July 15, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Hemostatic Clip
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type