The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteque A.v. Fistula Needle Set.
| Device ID | K993118 |
| 510k Number | K993118 |
| Device Name: | BIOTEQUE A.V. FISTULA NEEDLE SET |
| Classification | Needle, Fistula |
| 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 | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 1999-12-17 |
| Summary: | summary |