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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K854994
Device Name BARTELL SMALL INCISION LENS GLIDE
Applicant
Microtech, Inc.
2867 Mill Rd.
Doylestown,  PA  18901
Applicant Contact MICHAEL BARTELL
Correspondent
Microtech, Inc.
2867 Mill Rd.
Doylestown,  PA  18901
Correspondent Contact MICHAEL BARTELL
Regulation Number886.4300
Classification Product Code
KYB  
Date Received12/12/1985
Decision Date 02/04/1986
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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