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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 K940428
Device Name INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR
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 Received01/31/1994
Decision Date 04/25/1994
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
Predetermined Change
Control Plan Authorized		 No
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