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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 K952049
Device Name TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM
Applicant
Tissue Technologies, Inc.
6731 Academy Rd., NE
Albuquerque,  NM  87109
Applicant Contact MARIO BARTON
Correspondent
Tissue Technologies, Inc.
6731 Academy Rd., NE
Albuquerque,  NM  87109
Correspondent Contact MARIO BARTON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/01/1995
Decision Date 07/21/1995
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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