The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Intelijet Suction Supply.
Device ID | K922176 |
510k Number | K922176 |
Device Name: | INTELIJET SUCTION SUPPLY |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
Contact | Jeffery Green |
Correspondent | Jeffery Green SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-08 |
Decision Date | 1992-11-18 |