The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Richard-allan Vessel Loops.
Device ID | K900566 |
510k Number | K900566 |
Device Name: | RICHARD-ALLAN VESSEL LOOPS |
Classification | Instrument, Surgical, Disposable |
Applicant | RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
Contact | Nell Holdridge |
Correspondent | Nell Holdridge RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-07 |
Decision Date | 1990-05-03 |