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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K943508
Device Name INSUFFLATOR TUBING WITH FILTER
Applicant
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Applicant Contact MEG LANNOM
Correspondent
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Correspondent Contact MEG LANNOM
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/20/1994
Decision Date 11/17/1994
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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