510(k) K933171

INMAN IRRIGATION TAPERED PROBE by Inman Medical Corp. — Product Code KYZ

K933171 is an FDA 510(k) premarket notification submitted by Inman Medical Corp. for the device "INMAN IRRIGATION TAPERED PROBE". The FDA issued a decision of Substantially Equivalent on April 29, 1994. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Inman Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1994
Date Received
June 29, 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