The following data is part of a premarket notification filed by Uni-quatro Industries Canada, Inc. with the FDA for High Speed Core Cut Biopsy Gun.
| Device ID | K905556 |
| 510k Number | K905556 |
| Device Name: | HIGH SPEED CORE CUT BIOPSY GUN |
| Classification | Biopsy Needle |
| 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 | FCG |
| 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 |