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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 K943426
Device Name ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE
Applicant
Schoelly Technologies, Inc.
Two Oakwood Blvd. Suite 160
Hollywood,  FL  33020
Applicant Contact KENNETH J DURBIN
Correspondent
Schoelly Technologies, Inc.
Two Oakwood Blvd. Suite 160
Hollywood,  FL  33020
Correspondent Contact KENNETH J DURBIN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/15/1994
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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