The following data is part of a premarket notification filed by Loseff Medical Designers, Ltd. with the FDA for Loseff Balloon Type Self-retention Wound.
| Device ID | K801349 |
| 510k Number | K801349 |
| Device Name: | LOSEFF BALLOON TYPE SELF-RETENTION WOUND |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | LOSEFF MEDICAL DESIGNERS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-09 |
| Decision Date | 1980-08-07 |