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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 K972768
Device Name BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
Applicant
Blackstone Medical, Inc.
90 Brookdale Dr.
Springfield,  MA  01104
Applicant Contact JOSEPH S MOONEY
Correspondent
Blackstone Medical, Inc.
90 Brookdale Dr.
Springfield,  MA  01104
Correspondent Contact JOSEPH S MOONEY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/24/1997
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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