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510(k) K974288

ZEROWET SPLASHIELD by Zerowet, Inc. — Product Code KYZ

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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