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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K931103
Device Name STRYKER STAPLER SYSTEM
Applicant
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Applicant Contact CHARLES L NELSON
Correspondent
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Correspondent Contact CHARLES L NELSON
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GCJ  
Date Received03/03/1993
Decision Date 10/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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