The following data is part of a premarket notification filed by Goulter Medical, Inc. with the FDA for Zip Condom Catheter.
| Device ID | K964219 |
| 510k Number | K964219 |
| Device Name: | ZIP CONDOM CATHETER |
| Classification | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Applicant | GOULTER MEDICAL, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf GOULTER MEDICAL, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | EYZ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-22 |
| Decision Date | 1997-08-11 |
| Summary: | summary |