The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc (dba Medline Ren with the FDA for Medline Renewal Reprocessed Harmonic Ace+7 Shears.
| Device ID | K193563 |
| 510k Number | K193563 |
| Device Name: | Medline ReNewal Reprocessed Harmonic ACE+7 Shears |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Ave Redmond, OR 97756 |
| Contact | Gail Gassner |
| Correspondent | Gail Gassner Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Ave 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 | 2019-12-23 |
| Decision Date | 2020-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20193489081333 | K193563 | 000 |