510(k) K922176

INTELIJET SUCTION SUPPLY by Smith & Nephew Dyonics, Inc. — Product Code BTA

K922176 is an FDA 510(k) premarket notification submitted by Smith & Nephew Dyonics, Inc. for the device "INTELIJET SUCTION SUPPLY". The FDA issued a decision of Substantially Equivalent on November 18, 1992. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Smith & Nephew Dyonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1992
Date Received
May 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type