The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Tissue Expanders For Reconstruc-surgery 3600.
| Device ID | K845036 |
| 510k Number | K845036 |
| Device Name: | TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 |
| Classification | Expander, Skin, Inflatable |
| Applicant | PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Contact | Alfred A Iversen |
| Correspondent | Alfred A Iversen PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-27 |
| Decision Date | 1985-06-26 |