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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 K981235
Device Name OCULOSTAT
Applicant
LASER CENTER DEV. CORP.
1028 S. KIRKWOOD RD.
SUITE A
ST. LOUIS,  MO  63122 -7222
Applicant Contact FRANCIS E O'DONNELL
Correspondent
LASER CENTER DEV. CORP.
1028 S. KIRKWOOD RD.
SUITE A
ST. LOUIS,  MO  63122 -7222
Correspondent Contact FRANCIS E O'DONNELL
Regulation Number886.4350
Classification Product Code
HNC  
Date Received04/03/1998
Decision Date 07/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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