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FDA 510(k) Applications Submitted by IMAGYN MEDICAL TECHNOLOGIES, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K991526
05/03/1999
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
IMAGYN MEDICAL TECHNOLOGIES, INC.
K010166
01/18/2001
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
IMAGYN MEDICAL TECHNOLOGIES, INC.
K032491
08/12/2003
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
IMAGYN MEDICAL TECHNOLOGIES, INC.
K980096
01/09/1998
OAC (OPTICAL ASPIRATING CURETTE)
IMAGYN MEDICAL TECHNOLOGIES, INC.
K980291
01/26/1998
IMPOWER EXTERNAL VACUUM SYSTEM
IMAGYN MEDICAL TECHNOLOGIES, INC.
K974173
11/05/1997
ERECAID SYSTEM/STAY EREC SYSTEM
IMAGYN MEDICAL TECHNOLOGIES, INC.
K012706
08/14/2001
IM2001 PULSE OXIMETER
IMAGYN MEDICAL TECHNOLOGIES, INC.
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