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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837125
Device Name SYSTEM 900 TWO ROOM REMOTE FIBERS
Applicant
Coherent Radiation Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Coherent Radiation Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received02/04/1983
Decision Date 03/04/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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