The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Modification To Temno Biopsy Needles.
| Device ID | K024120 |
| 510k Number | K024120 |
| Device Name: | MODIFICATION TO TEMNO BIOPSY NEEDLES |
| Classification | Biopsy Needle |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450443365 | K024120 | 000 |
| 20884450443372 | K024120 | 000 |
| 20884450443495 | K024120 | 000 |
| 20884450443631 | K024120 | 000 |
| 20884450443587 | K024120 | 000 |
| 20884450443518 | K024120 | 000 |
| 20884450443570 | K024120 | 000 |
| 20884450443624 | K024120 | 000 |
| 20884450443617 | K024120 | 000 |
| 20884450443549 | K024120 | 000 |
| 20884450443471 | K024120 | 000 |
| 20884450443648 | K024120 | 000 |
| 20884450443556 | K024120 | 000 |
| 20884450443464 | K024120 | 000 |
| 20884450443235 | K024120 | 000 |
| 20884450443402 | K024120 | 000 |
| 20884450443600 | K024120 | 000 |
| 20884450443242 | K024120 | 000 |
| 20884450443396 | K024120 | 000 |
| 20884450443419 | K024120 | 000 |
| 20884450443563 | K024120 | 000 |
| 20884450443389 | K024120 | 000 |
| 20884450443426 | K024120 | 000 |
| 20884450443358 | K024120 | 000 |
| 20884450443525 | K024120 | 000 |