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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K896471
Device Name TENSTAPLE ORTHOPEDIC STAPLING SYSTEM
Applicant
Tenstaple, Inc.
1178 Wisteria Dr.
Melvern,  PA  19355
Applicant Contact PERK CROOK
Correspondent
Tenstaple, Inc.
1178 Wisteria Dr.
Melvern,  PA  19355
Correspondent Contact PERK CROOK
Regulation Number888.3030
Classification Product Code
JDR  
Date Received11/13/1989
Decision Date 07/24/1990
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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