510(k) K851795

41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS by Artiberia — Product Code KAE

K851795 is an FDA 510(k) premarket notification submitted by Artiberia for the device "41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code KAE (Forceps, Ent), a Class I device regulated under 21 CFR 874.4420. Artiberia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type