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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K861491
Device Name ROPHAE DIAMOND KNIFE
Applicant
Rophae Lens Co., Inc.
300 Bldg. W., Suite 208
3151 3rd Ave. N.
St. Petersburg,  FL  33713
Applicant Contact DENNIS A THACKRAY
Correspondent
Rophae Lens Co., Inc.
300 Bldg. W., Suite 208
3151 3rd Ave. N.
St. Petersburg,  FL  33713
Correspondent Contact DENNIS A THACKRAY
Regulation Number886.4350
Classification Product Code
HNN  
Date Received04/22/1986
Decision Date 05/28/1986
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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