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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 K931518
Device Name IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE
Applicant
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Applicant Contact VAN OSDEL
Correspondent
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Correspondent Contact VAN OSDEL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/26/1993
Decision Date 08/18/1993
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
Predetermined Change
Control Plan Authorized		 No
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