The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Dual Fluid Irrigating Syringe.
Device ID | K964833 |
510k Number | K964833 |
Device Name: | RMI DUAL FLUID IRRIGATING SYRINGE |
Classification | Syringe, Irrigating (non Dental) |
Applicant | RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
Contact | Rd Hibbert |
Correspondent | Rd Hibbert RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
Product Code | KYZ |
CFR Regulation Number | 880.6960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-02 |
Decision Date | 1997-02-19 |
Summary: | summary |