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510(k) K882071

CRANK FRAME RETRACTOR by Karlin Technology, Inc. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1988
Date Received
May 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

Other clearances by Karlin Technology, Inc.

  • K903969 — SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET (September 5, 1990)
  • K893203 — BONE SCREW (April 4, 1990)
  • K893201 — BONE PLATE (April 4, 1990)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K882519 — X-RAY MARKER (August 9, 1988)
  • K882073 — SPINAL NEEDLE (July 18, 1988)
  • K882520 — SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS (July 18, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTES (June 17, 1988)
  • K882077 — MICRODISCECTOMY CURRETTES (June 17, 1988)

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