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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K952687
Device Name PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
Applicant
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Applicant Contact JOHN D PAULSON
Correspondent
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Correspondent Contact JOHN D PAULSON
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
HRX   MBI  
Date Received06/12/1995
Decision Date 02/06/1996
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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