The following data is part of a premarket notification filed by Surgical Instrument Services And Savings, Inc with the FDA for Medline Renewal Reprocessed Harmonic Focus+ Shears Without Adaptive Tissue Technology.
| Device ID | K150524 |
| 510k Number | K150524 |
| Device Name: | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears Without Adaptive Tissue Technology |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | Surgical Instrument Services And Savings, Inc (dba Medline ReNewal) 2747 SW 6th ST. Redmond, OR 97756 |
| Contact | Richard D Wynkoop |
| Correspondent | Brandi Panteleon Surgical Instrument Services And Savings, Inc (dba Medline ReNewal) 2747 SW 6th ST. Redmond, OR 97756 |
| Product Code | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-12-16 |
| Summary: | summary |