The following data is part of a premarket notification filed by Opticon Medical, Inc. with the FDA for Opticon Direct Male Urinary Catheter For Continuous Drainage.
| Device ID | K970716 |
| 510k Number | K970716 |
| Device Name: | OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | OPTICON MEDICAL, INC. 14505 21ST AVENUE NORTH SUITE #216 Minneapolis, MN 55447 |
| Contact | Greg Sachs |
| Correspondent | Greg Sachs OPTICON MEDICAL, INC. 14505 21ST AVENUE NORTH SUITE #216 Minneapolis, MN 55447 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-27 |
| Decision Date | 1997-05-16 |
| Summary: | summary |