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FDA 510(k) Applications Submitted by GYNECARE INNOVATION CENTER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K971305
04/08/1997
FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
GYNECARE INNOVATION CENTER
K980393
02/02/1998
SOPRANO CRYO-THERAPY SYSTEM
GYNECARE INNOVATION CENTER
K964892
12/06/1996
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
GYNECARE INNOVATION CENTER
K962506
06/27/1996
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
GYNECARE INNOVATION CENTER
K963872
09/26/1996
FEMRX MORCELLATOR SYSTEM
GYNECARE INNOVATION CENTER
K954648
10/10/1995
FEMRX OPERASTAR SYSTEM
GYNECARE INNOVATION CENTER
K954775
10/17/1995
FLO-STAT FLUID MONITORING SYSTEM
GYNECARE INNOVATION CENTER
K964441
11/06/1996
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
GYNECARE INNOVATION CENTER
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