510(k) K911756

POSTERIOR NASAL EPISTAXIS INSTRUMENTS by Richard Wolf Medical Instruments Corp. — Product Code ECB

K911756 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "POSTERIOR NASAL EPISTAXIS INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on October 24, 1991. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1991
Date Received
April 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Syringe, Air And/Or Water
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type