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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 K973576
Device Name EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM
Applicant
Epulse Technologies, Inc.
4838 Bentree Ave.
Long Beach,  CA  90807
Applicant Contact SANFORD DAMASCO
Correspondent
Epulse Technologies, Inc.
4838 Bentree Ave.
Long Beach,  CA  90807
Correspondent Contact SANFORD DAMASCO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/10/1997
Decision Date 12/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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