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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K871517
Device Name OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
Applicant
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact WAYNE LIPSON
Correspondent
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact WAYNE LIPSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/20/1987
Decision Date 11/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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