510(k) K982435

IRRIGATION SYRINGE KIT by Sub-Q, Inc. — Product Code KYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
July 13, 1998
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