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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K940232
Device Name INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
Applicant
INNERDYNE MEDICAL, INC.
1244 REAMWOOD AVE.
SUNNYVALE,  CA  94089
Applicant Contact COLIN J NICHOLS
Correspondent
INNERDYNE MEDICAL, INC.
1244 REAMWOOD AVE.
SUNNYVALE,  CA  94089
Correspondent Contact COLIN J NICHOLS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/14/1994
Decision Date 04/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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