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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 K864063
Device Name ORION 3001, LASER PHOTOCOAGULATOR
Applicant
G. Rodenstock Instrumente GmbH
Drachenseestrabe 10-12
Postfach 701560, D-8000
Munchen 70, West Germany,  DE
Applicant Contact PRATSCH
Correspondent
G. Rodenstock Instrumente GmbH
Drachenseestrabe 10-12
Postfach 701560, D-8000
Munchen 70, West Germany,  DE
Correspondent Contact PRATSCH
Regulation Number886.4390
Classification Product Code
HQF  
Date Received10/20/1986
Decision Date 11/13/1986
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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