510(k) K884373
K884373 is an FDA 510(k) premarket notification submitted by Micrins, Ltd. for the device "KORBER ARTERIOTOMY SCISSORS". The FDA issued a decision of Substantially Equivalent on November 8, 1988. The device falls under product code LRW (Scissors, General, Surgical), a Class I device regulated under 21 CFR 878.4800. Micrins, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1988
- Date Received
- October 18, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scissors, General, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type