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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K935237
Device Name STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
Applicant
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Applicant Contact THOMAS KELLY
Correspondent
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Correspondent Contact THOMAS KELLY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/01/1993
Decision Date 03/21/1994
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
Recalls CDRH Recalls
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