The following data is part of a premarket notification filed by Richard-allan Medical with the FDA for Richard-allan Clamp Covers.
Device ID | K905682 |
510k Number | K905682 |
Device Name: | RICHARD-ALLAN CLAMP COVERS |
Classification | Tray, Surgical, Instrument |
Applicant | RICHARD-ALLAN MEDICAL 8850M89, BOX 351 Richland, MI 49083 |
Contact | Dave Cole |
Correspondent | Dave Cole RICHARD-ALLAN MEDICAL 8850M89, BOX 351 Richland, MI 49083 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-19 |
Decision Date | 1991-02-19 |