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510(k) K974288

ZEROWET SPLASHIELD by Zerowet, Inc. — Product Code KYZ

K974288 is an FDA 510(k) premarket notification submitted by Zerowet, Inc. for the device "ZEROWET SPLASHIELD". The FDA issued a decision of Substantially Equivalent on January 29, 1998. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1998
Date Received
November 14, 1997
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

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  • K991254 — QS DELIVERY SYSTEM (August 23, 1999)
  • K982435 — IRRIGATION SYRINGE KIT (November 6, 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)
  • K952407 — REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (August 7, 1995)

FDA data resources