The following data is part of a premarket notification filed by Rzv Medical Specialties, Inc. with the FDA for Germ Trapper Suction Tube Holder.
Device ID | K972372 |
510k Number | K972372 |
Device Name: | GERM TRAPPER SUCTION TUBE HOLDER |
Classification | Catheter And Tip, Suction |
Applicant | RZV MEDICAL SPECIALTIES, INC. 34 THORNCREST DR. Pittsburgh, PA 15235 |
Contact | Linda K Ruvo |
Correspondent | Linda K Ruvo RZV MEDICAL SPECIALTIES, INC. 34 THORNCREST DR. Pittsburgh, PA 15235 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-25 |
Decision Date | 1997-12-11 |