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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, laparoscopic
510(k) Number K003792
Device Name STRYKER HEATED INSUFFLATOR TUBE SET
Applicant
STRYKER CORP.
2590 WALSH AVE.
SANTA CLARA,  CA  95051
Applicant Contact MICHAEL BAYCURA
Correspondent
STRYKER CORP.
2590 WALSH AVE.
SANTA CLARA,  CA  95051
Correspondent Contact MICHAEL BAYCURA
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/08/2000
Decision Date 02/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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