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510(k) K953360

R-MED ABDOMINAL WALL ELEVATOR by R-Med, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1996
Date Received
July 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

Other clearances by R-Med, Inc.

  • K001236 — RIZA BAND STRETCHER (RBS)-60000 (July 17, 2000)
  • K954882 — RIZA-RIBE NEEDLE (MODIFICATION) (November 16, 1995)
  • K953441 — RIZA-RIBE NEEDLE (August 18, 1995)
  • K950108 — R-MED MINI-RETRACTOR (May 11, 1995)
  • K942411 — R-MED DISPOSABLE PLUG (March 31, 1995)
  • K945637 — R-MED MOTORIZED LAPAROSCOPIC HANDLE (December 7, 1994)
  • K943818 — MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS (August 29, 1994)
  • K935031 — RIZA-RIBE NEEDLE (April 25, 1994)

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