OLYMPUS PK TP(TM) SYSTEM, MODIFICATION— 510(k) K911640

Name: FDA 510(k) clearance K911640
Creator: U.S. Food and Drug Administration
Published: 1991-07-24

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K911640 for OLYMPUS PK TP(TM) SYSTEM, MODIFICATION, Substantially Equivalent on 1991-07-24. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code GMT
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1991-04-08
Decision date: 1991-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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