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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Specula, Ophthalmic
510(k) Number K801969
FOIA Releasable 510(k) K801969
Device Name ASNIS GUIDED SCREW SYSTEMS
Applicant
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4350
Classification Product Code
HNC  
Date Received08/19/1980
Decision Date 08/27/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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