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510(k) K050797

TISSU-TRANS by Shippert Medical Technologies Corp. — Product Code KYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2005
Date Received
March 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
Submission Type

Other clearances by Shippert Medical Technologies Corp.

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  • K092482 — TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 (December 4, 2009)
  • K092022 — TISSU TRANS HARVEST TUBING (August 17, 2009)
  • K964855 — EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD (March 4, 1997)
  • K964334 — EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) (December 9, 1996)
  • K963704 — MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (November 26, 1996)
  • K962133 — EXPANDACELL INJECTO-PAK (August 1, 1996)
  • K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
  • K960228 — EXPANDACELL INJECTO-PAK NASAL PACK (February 27, 1996)
  • K955593 — EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (December 22, 1995)

Other clearances for product code KYZ

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  • K102563 — SINGLE CANNULA EXTENDED APPLICATOR (March 15, 2011)
  • K092022 — TISSU TRANS HARVEST TUBING (August 17, 2009)
  • K991254 — QS DELIVERY SYSTEM (August 23, 1999)
  • K982435 — IRRIGATION SYRINGE KIT (November 6, 1998)
  • K974288 — ZEROWET SPLASHIELD (January 29, 1998)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K960725 — MARPP PRESSURE MONITORING SYSTEM (July 15, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)
  • K952406 — REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLO (August 7, 1995)