The following data is part of a premarket notification filed by Medical Marketing Group with the FDA for Disposable Urinary Legbag W/strap.
| Device ID | K821168 |
| 510k Number | K821168 |
| Device Name: | DISPOSABLE URINARY LEGBAG W/STRAP |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
| Contact | Timothy D Golden |
| Correspondent | Timothy D Golden MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-24 |