510(k) K931912

IRRIGATING BLUNT DISSECTOR by Mayaguez Medical Center — Product Code KYZ

K931912 is an FDA 510(k) premarket notification submitted by Mayaguez Medical Center for the device "IRRIGATING BLUNT DISSECTOR". The FDA issued a decision of Substantially Equivalent on August 10, 1993. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Mayaguez Medical Center has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1993
Date Received
April 16, 1993
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