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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
Applicant Contact FRANCIS E O'DONNELL
Correspondent
Laser Center Dev. Corp.
1028 S. Kirkwood Rd.
Suite A
St. Louis,  MO  63122
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
Predetermined Change
Control Plan Authorized		 No
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