510(k) K890243

DRESSING FORCEPS by Kinetic Medical Products — Product Code EFL

K890243 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "DRESSING FORCEPS". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code EFL (Forceps, Dressing, Dental), a Class I device regulated under 21 CFR 872.4565. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
January 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Dressing, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type