The following data is part of a premarket notification filed by Clear Medical, Inc. with the FDA for Reprocessed Multiple Clip Appliers.
| Device ID | K033579 |
| 510k Number | K033579 |
| Device Name: | REPROCESSED MULTIPLE CLIP APPLIERS |
| Classification | Clip, Implantable, Reprocessed |
| Applicant | CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue, WA 98005 |
| Contact | Mike Kovacs |
| Correspondent | Mike Kovacs CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue, WA 98005 |
| Product Code | NMJ |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-13 |
| Decision Date | 2005-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551019095 | K033579 | 000 |
| 10888551019088 | K033579 | 000 |
| 10888551019071 | K033579 | 000 |
| 10888551019064 | K033579 | 000 |
| 10888551019057 | K033579 | 000 |
| 10888551018944 | K033579 | 000 |
| 10888551018937 | K033579 | 000 |
| 10888551018920 | K033579 | 000 |