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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
Applicant
Full Spectrum, Inc.
2515 Elwood Dr., Suite 108
Ames,  IA  50010
Applicant Contact GERALD J SHIRK
Correspondent
Full Spectrum, Inc.
2515 Elwood Dr., Suite 108
Ames,  IA  50010
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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