The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Injection Cap, Luer Lock.
Device ID | K812657 |
510k Number | K812657 |
Device Name: | INJECTION CAP, LUER LOCK |
Classification | Set, Administration, Intravascular |
Applicant | PROCEDURE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-18 |
Decision Date | 1981-10-23 |