The following data is part of a premarket notification filed by Proact, Ltd. with the FDA for Bauer Temno Biopsy Needle.
| Device ID | K902319 |
| 510k Number | K902319 |
| Device Name: | BAUER TEMNO BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | PROACT, LTD. CALDER SQUARE BOX 11029 State College, PA 16805 |
| Contact | John N Zink |
| Correspondent | John N Zink PROACT, LTD. CALDER SQUARE BOX 11029 State College, PA 16805 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-23 |
| Decision Date | 1990-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450444027 | K902319 | 000 |
| 20884450444584 | K902319 | 000 |
| 20884450444669 | K902319 | 000 |
| 20884450444591 | K902319 | 000 |
| 20884450444089 | K902319 | 000 |
| 20884450444539 | K902319 | 000 |
| 20884450444164 | K902319 | 000 |
| 20884450444652 | K902319 | 000 |
| 20884450444461 | K902319 | 000 |
| 20884450444386 | K902319 | 000 |
| 20884450444447 | K902319 | 000 |
| 20884450444126 | K902319 | 000 |
| 20884450444416 | K902319 | 000 |
| 20884450444522 | K902319 | 000 |
| 20884450444355 | K902319 | 000 |
| 20884450444225 | K902319 | 000 |
| 20884450444607 | K902319 | 000 |
| 20884450444065 | K902319 | 000 |
| 20884450444270 | K902319 | 000 |
| 20884450444249 | K902319 | 000 |
| 20884450444034 | K902319 | 000 |
| 20884450444188 | K902319 | 000 |
| 20884450444157 | K902319 | 000 |
| 20884450444119 | K902319 | 000 |
| 20884450444171 | K902319 | 000 |
| 20884450444560 | K902319 | 000 |
| 20884450444058 | K902319 | 000 |
| 20884450444140 | K902319 | 000 |
| 20884450444553 | K902319 | 000 |
| 20884450444492 | K902319 | 000 |