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510(k) K924117

DEXIDE LAPAROSCOPIC KITS by Dexide, Inc. — Product Code KDD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 23, 1993
Date Received
August 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K944509 — DEXIDE INSUFFLATION TUBING WITH FILTER (February 7, 1995)
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  • K921709 — ENDOBAG, MODIFICATION (July 14, 1992)
  • K913762 — MONOSCOPY(TM) BRAND, ENDOBAG (October 28, 1991)
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  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
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  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)