510(k) K892823
K892823 is an FDA 510(k) premarket notification submitted by The South India Surgical Co. Pvt. , Ltd. for the device "PLASTER CUTTING SCISSORS". The FDA issued a decision of Substantially Equivalent on May 25, 1989. The device falls under product code LRW (Scissors, General, Surgical), a Class I device regulated under 21 CFR 878.4800. The South India Surgical Co. Pvt. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 1989
- Date Received
- April 11, 1989
- 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