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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 K955758
Device Name INDIGO MEDICAL MODEL IDL 830E
Applicant
Indigo Medical, Inc.
1049 Elwell Ct.
Palo Alto,  CA  94303
Applicant Contact ALEX AXELROD
Correspondent
Indigo Medical, Inc.
1049 Elwell Ct.
Palo Alto,  CA  94303
Correspondent Contact ALEX AXELROD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/19/1995
Decision Date 02/16/1996
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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