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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 K910532
Device Name URAM OPHTHALMIC LASER ENDOSCOPE
Applicant
MARTIN S. KNOPF ASSOC., INC.
28 MARIGOLD LN.
marlboro,  NJ  07746
Applicant Contact martin s knopf
Correspondent
MARTIN S. KNOPF ASSOC., INC.
28 MARIGOLD LN.
marlboro,  NJ  07746
Correspondent Contact martin s knopf
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
KYH  
Date Received02/08/1991
Decision Date 05/28/1991
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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