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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K955862
Device Name FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201
Original Applicant
FULL SPECTRUM, INC.
2515 elwood dr., suite 108
ames,  IA  50010
Original Contact gerald j shirk
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/27/1995
Decision Date 03/01/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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