The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Foerster Mammary Bandage.
| Device ID | K800249 |
| 510k Number | K800249 |
| Device Name: | SURGITEK FOERSTER MAMMARY BANDAGE |
| Classification | Fiber, Medical, Absorbent |
| Applicant | MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRL |
| CFR Regulation Number | 880.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-06 |
| Decision Date | 1980-02-19 |