The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology.
| Device ID | K133672 |
| 510k Number | K133672 |
| Device Name: | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST DRAKE DRIVE Tempe, AZ 85283 |
| Contact | Scott English |
| Correspondent | Scott English STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST 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 | 2013-11-29 |
| Decision Date | 2014-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825017348 | K133672 | 000 |
| 30885825017331 | K133672 | 000 |