The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Caraflex Elastic Polymer Plaster Banda.
Device ID | K813219 |
510k Number | K813219 |
Device Name: | CARAFLEX ELASTIC POLYMER PLASTER BANDA |
Classification | Bandage, Cast |
Applicant | CARAPACE, INC. 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 | 1981-11-09 |
Decision Date | 1981-12-17 |