The following data is part of a premarket notification filed by Spectrum Medsystems Corp. with the FDA for Uni-gard Quik Cath(sizes 8 French Through 18)ug 10008,10010,10012,10014,10016,10018.
| Device ID | K961906 |
| 510k Number | K961906 |
| Device Name: | UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 |
| Classification | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Applicant | SPECTRUM MEDSYSTEMS CORP. 2166 MICHELSON DR. Irvine, CA 92715 -1304 |
| Contact | Thomas L Hursman |
| Correspondent | Thomas L Hursman SPECTRUM MEDSYSTEMS CORP. 2166 MICHELSON DR. Irvine, CA 92715 -1304 |
| Product Code | EYZ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-16 |
| Decision Date | 1996-11-19 |
| Summary: | summary |