The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteque Hemodialysis Blood Tubing Set.
| Device ID | K992930 |
| 510k Number | K992930 |
| Device Name: | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | BIOTEQUE CORP. 900 N. SWITZER CANYON DR. #142 Flagstaff, AZ 86001 |
| Contact | Allen Reich |
| Correspondent | Allen Reich BIOTEQUE CORP. 900 N. SWITZER CANYON DR. #142 Flagstaff, AZ 86001 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-31 |
| Decision Date | 2000-02-09 |
| Summary: | summary |