The following data is part of a premarket notification filed by Uni-quatro Industries Canada, Inc. with the FDA for Ccc Crown-core-cut-needle.
Device ID | K905557 |
510k Number | K905557 |
Device Name: | CCC CROWN-CORE-CUT-NEEDLE |
Classification | Instrument, Biopsy |
Applicant | UNI-QUATRO INDUSTRIES CANADA, INC. 6471 KISTER RD. Niagara Falls, Ontario, CA L2e 6x8 |
Contact | Siegfried Gruchot |
Correspondent | Siegfried Gruchot UNI-QUATRO INDUSTRIES CANADA, INC. 6471 KISTER RD. Niagara Falls, Ontario, CA L2e 6x8 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-11 |
Decision Date | 1991-03-08 |