The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Carter-thomason Needle Point Suture Passer.
| Device ID | K182828 |
| 510k Number | K182828 |
| Device Name: | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | Surgical Instrument Service And Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Contact | Stephanie Boyle Mays |
| Correspondent | Stephanie Boyle Mays Surgical Instrument Service And Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-05 |
| Decision Date | 2019-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20193489000631 | K182828 | 000 |