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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
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