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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 K882908
Device Name SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
Applicant
SURGICAL LASER TECHNOLOGIES, INC.
ONE GREAT VALLEY PKWY.
MALVERN,  PA  19355
Applicant Contact GIFFORD, R.N.
Correspondent
SURGICAL LASER TECHNOLOGIES, INC.
ONE GREAT VALLEY PKWY.
MALVERN,  PA  19355
Correspondent Contact GIFFORD, R.N.
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/12/1988
Decision Date 09/30/1988
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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