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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 K941419
Device Name DISPOSABLE SPINAL INTRODUCER SHEATH
Applicant
Trimedyne, Inc.
2801 Barranca Rd.
P.O. Box 57001
Irvine,  CA  92619
Applicant Contact PETER HYDE
Correspondent
Trimedyne, Inc.
2801 Barranca Rd.
P.O. Box 57001
Irvine,  CA  92619
Correspondent Contact PETER HYDE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/23/1994
Decision Date 06/21/1994
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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