The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Titanium Ligating Clips.
Device ID | K896262 |
510k Number | K896262 |
Device Name: | TITANIUM LIGATING CLIPS |
Classification | Applier, Hemostatic Clip |
Applicant | RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
Contact | Julie Powell |
Correspondent | Julie Powell RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
Product Code | HBT |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-30 |
Decision Date | 1990-01-02 |