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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K013513
Device Name DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
Applicant
Pain Concepts, Inc.
8001 Irvine Center Dr.
4th Floor
Irvine,  CA  92618
Applicant Contact RUSSELL PFLUEGER
Correspondent
Pain Concepts, Inc.
8001 Irvine Center Dr.
4th Floor
Irvine,  CA  92618
Correspondent Contact RUSSELL PFLUEGER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/22/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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