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510(k) K954775

FLO-STAT FLUID MONITORING SYSTEM by Gynecare Innovation Center — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1996
Date Received
October 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

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  • K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION (March 28, 1997)
  • K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) (February 4, 1997)
  • K963872 — FEMRX MORCELLATOR SYSTEM (January 17, 1997)
  • K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] (September 16, 1996)
  • K954648 — FEMRX OPERASTAR SYSTEM (March 14, 1996)

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