The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Protector Ii.
Device ID | K790661 |
510k Number | K790661 |
Device Name: | PROTECTOR II |
Classification | Container, Sharps |
Applicant | RICHARD-ALLAN MEDICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-02 |
Decision Date | 1979-04-12 |