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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 K954931
Device Name NEO-MED DLS-1100
Applicant
Neo-Laboratories, LLC
1348 Market St.
Suite 207
Redding,  CA  96001
Applicant Contact CHERYL M COSTER
Correspondent
Neo-Laboratories, LLC
1348 Market St.
Suite 207
Redding,  CA  96001
Correspondent Contact CHERYL M COSTER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/25/1995
Decision Date 12/18/1995
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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