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 |