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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 K971083
Device Name ARTHROSCOPE
Applicant
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Applicant Contact JON CAPAROTTA
Correspondent
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Correspondent Contact JON CAPAROTTA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/25/1997
Decision Date 06/23/1997
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
Recalls CDRH Recalls
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