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510(k) K880998

STERNUM SPREADER, PEDIATRIC by T. Korossurgical Instruments Corp. — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1988
Date Received
March 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by T. Korossurgical Instruments Corp.

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  • K953998 — DISCETOME TISSUE ASPIRATOR (December 4, 1995)
  • K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (November 6, 1995)
  • K954052 — ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (November 6, 1995)
  • K935529 — CERVICAL SELF-RETAINING RETRACTOR (March 22, 1994)
  • K931262 — REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR (August 6, 1993)
  • K926585 — THOROCOSCOPY SELF-RETAINING RETRACTOR (August 6, 1993)
  • K926583 — REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR (August 6, 1993)

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  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
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  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
  • K943875 — VILLALTA RETRACTOR (November 9, 1994)