510(k) K941565

JARIT RECOMMENDED SINUS INSTRUMENTS by J. Jamner Surgical Instruments, Inc. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1994
Date Received
April 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).