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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 K843646
Device Name STEINWAY MICRO-KERATO-TREPHINE
Applicant
Steinway Instrument Co., Inc.
5466 Complex St. #205
San Diego,  CA  92123
Applicant Contact LOREN HENDRICKS
Correspondent
Steinway Instrument Co., Inc.
5466 Complex St. #205
San Diego,  CA  92123
Correspondent Contact LOREN HENDRICKS
Regulation Number886.4350
Classification Product Code
HRH  
Date Received09/17/1984
Decision Date 01/03/1985
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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