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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trephine, Manual, Ophthalmic
510(k) Number K931792
Device Name ARTHROSCOPE
Applicant
Intramed Laboratories, Inc.
11100 Roselle St.
San Diego,  CA  92121
Applicant Contact STEPHEN SOSNOWSKI
Correspondent
Intramed Laboratories, Inc.
11100 Roselle St.
San Diego,  CA  92121
Correspondent Contact STEPHEN SOSNOWSKI
Regulation Number886.4350
Classification Product Code
HRH  
Date Received04/12/1993
Decision Date 06/13/1994
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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