FDA 510(k) Premarket Notification K935716: KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE

Submission Details & Decision

Normalized public record details for 510(k) notification K935716.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K935716

Applicant / Sponsor

KARL STORZ Endoscopy-America, Inc.

Device Name

KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE

Product Code

HIH

Decision Date

1995-11-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Obstetrics/Gynecology (OB)

Clearance Type

Traditional

Third Party Flag

Date Received

1993-11-30

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