510(k) K895762

CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC by Kolster Methods — Product Code GEA

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