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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 K931278
Device Name INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
Applicant
INTERVENTIONAL THERAPEUTICS CORP.
2665 MARINE WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact COLIN J NICHOLS
Correspondent
INTERVENTIONAL THERAPEUTICS CORP.
2665 MARINE WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact COLIN J NICHOLS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/08/1993
Decision Date 07/23/1993
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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