The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Harmonic Focus Shears + Adaptive Tissue Technology.
| Device ID | K170456 |
| 510k Number | K170456 |
| Device Name: | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Contact | Chelsea Cullen |
| Correspondent | Chelsea Cullen Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| 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 | 2017-02-15 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327348249 | K170456 | 000 |