The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Sterile Protective Sleeve W/tough-borst.
Device ID | K822290 |
510k Number | K822290 |
Device Name: | STERILE PROTECTIVE SLEEVE W/TOUGH-BORST |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-02 |
Decision Date | 1982-08-31 |