510(k) K950337

KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL by KARL STORZ Endoscopy-America, Inc. — Product Code EQJ

K950337 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL". The FDA issued a decision of Substantially Equivalent on August 23, 1995. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1995
Date Received
January 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type