The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Hot Biopsy Forceps.
| Device ID | K050136 |
| 510k Number | K050136 |
| Device Name: | REPROCESSED HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Bruce R Lester |
| Correspondent | Bruce R Lester STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NLU |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-21 |
| Decision Date | 2005-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551013499 | K050136 | 000 |
| 10888551013482 | K050136 | 000 |
| 10888551007962 | K050136 | 000 |
| 10888551001717 | K050136 | 000 |
| 10888551001663 | K050136 | 000 |