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510(k) K013437

SF SH CATHETER, MODEL R65-945 by A & A Medical, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2001
Date Received
October 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by A & A Medical, Inc.

  • K013491 — HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 (November 19, 2001)
  • K003949 — TACKER, MODEL R65-933 (July 25, 2001)
  • K011512 — MMODIFICATION TO LAMINARIA (July 9, 2001)
  • K010510 — BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 (May 16, 2001)
  • K010789 — CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, (April 27, 2001)
  • K010056 — UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 (February 1, 2001)
  • K000027 — INSUFFLATION NEEDLE, MODEL R65-933 (April 3, 2000)
  • K994256 — SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (February 3, 2000)
  • K974038 — THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPR (May 11, 1998)
  • K974138 — ROCKET ELECTRODE (January 30, 1998)

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  • K222798 — Rejoni Intrauterine Catheter (December 16, 2022)
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