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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K941367
Device Name WEBB-MORLEY SPINE SYSTEM
Applicant
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Applicant Contact SHARON A STAROWICZ
Correspondent
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Correspondent Contact SHARON A STAROWICZ
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/21/1994
Decision Date 12/05/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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