KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS— 510(k) K950639

Name: FDA 510(k) clearance K950639
Creator: U.S. Food and Drug Administration
Published: 1995-06-19

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K950639 for KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS, Substantially Equivalent on 1995-06-19. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code MOK
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 1995-02-13
Decision date: 1995-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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