The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Cold Biopsy Forceps.
| Device ID | K042648 |
| 510k Number | K042648 |
| Device Name: | REPROCESSED COLD BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Non-electric, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Bruce Lester |
| Correspondent | Bruce Lester STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NON |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-28 |
| Decision Date | 2005-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551007955 | K042648 | 000 |
| 10888551001670 | K042648 | 000 |
| 10888551001632 | K042648 | 000 |
| 10888551001625 | K042648 | 000 |
| 10888551001618 | K042648 | 000 |
| 10888551001601 | K042648 | 000 |
| 10888551001595 | K042648 | 000 |
| 10888551001588 | K042648 | 000 |
| 10888551001571 | K042648 | 000 |
| 10888551001564 | K042648 | 000 |
| 10888551001557 | K042648 | 000 |
| 10888551001540 | K042648 | 000 |
| 10888551001687 | K042648 | 000 |
| 10888551001694 | K042648 | 000 |
| 10888551001700 | K042648 | 000 |
| 10888551013475 | K042648 | 000 |
| 10888551013468 | K042648 | 000 |
| 10888551013451 | K042648 | 000 |
| 10888551013444 | K042648 | 000 |
| 10888551013437 | K042648 | 000 |
| 10888551013420 | K042648 | 000 |
| 10888551001762 | K042648 | 000 |
| 10888551001755 | K042648 | 000 |
| 10888551001748 | K042648 | 000 |
| 10888551001731 | K042648 | 000 |
| 10888551001724 | K042648 | 000 |
| 10888551001496 | K042648 | 000 |