510(k) K895762
K895762 is an FDA 510(k) premarket notification submitted by Kolster Methods for the device "CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC". The FDA issued a decision of Substantially Equivalent on October 18, 1989. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Kolster Methods has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1989
- Date Received
- September 26, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type