The following data is part of a premarket notification filed by Ipos Luneburg with the FDA for Ipocon 7.
Device ID | K800749 |
510k Number | K800749 |
Device Name: | IPOCON 7 |
Classification | Bandage, Cast |
Applicant | IPOS LUNEBURG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ITG |
CFR Regulation Number | 890.3025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-04 |
Decision Date | 1980-07-28 |