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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 K022836
Device Name STEPHENS DISPOSABLE SPECULUM
Applicant
Stephens Instruments
2500 Sandersville Rd.
Lexington,  KY  40511
Applicant Contact ARCHANA JOHNSON
Correspondent
Stephens Instruments
2500 Sandersville Rd.
Lexington,  KY  40511
Correspondent Contact ARCHANA JOHNSON
Regulation Number886.4350
Classification Product Code
HNC  
Date Received08/27/2002
Decision Date 11/01/2002
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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