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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 K951996
Device Name IMAGYN ENDOSCOPE
Applicant
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Applicant Contact DEBRA A RINDERER
Correspondent
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Correspondent Contact DEBRA A RINDERER
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HRX  
Date Received04/28/1995
Decision Date 09/01/1995
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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