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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Ac-Powered
510(k) Number K923435
Device Name CORNEAL TOPOGRAPHY SYSTEM
Applicant
Par Microsystems Corp.
220 Seneca Tpke.
New Hartford,  NY  13413
Applicant Contact JOHN NABORS
Correspondent
Par Microsystems Corp.
220 Seneca Tpke.
New Hartford,  NY  13413
Correspondent Contact JOHN NABORS
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received07/13/1992
Decision Date 02/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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