The following data is part of a premarket notification filed by Conco Medical Co. with the FDA for Rapido-lastic In Sterile Form.
Device ID | K821701 |
510k Number | K821701 |
Device Name: | RAPIDO-LASTIC IN STERILE FORM |
Classification | Gauze/sponge, Internal |
Applicant | CONCO MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-08 |
Decision Date | 1982-07-22 |