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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 K050807
Device Name 20G SMA LASER FIBER, MODEL LF100
Applicant
OPHTHALMED LLC
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
OPHTHALMED LLC
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number886.4390
Classification Product Code
HQF  
Date Received03/30/2005
Decision Date 09/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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