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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K926470
Device Name LASER AND EMPHASIS SCLEROSTOMY TIP
Applicant
Summit Technology, Inc.
21 Hickory Dr.
Waltham,  MA  02154
Applicant Contact MAUREEN A O'CONNELL
Correspondent
Summit Technology, Inc.
21 Hickory Dr.
Waltham,  MA  02154
Correspondent Contact MAUREEN A O'CONNELL
Regulation Number886.4390
Classification Product Code
HQF  
Date Received12/28/1992
Decision Date 07/22/1993
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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