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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
Predetermined Change
Control Plan Authorized		 No
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