The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Arthrocare Arthrowands And Smith & Nephew Dyonics.
| Device ID | K171324 |
| 510k Number | K171324 |
| Device Name: | Medline ReNewal Reprocessed ArthroCare ArthroWands And Smith & Nephew Dyonics |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Surgical Instrument Service And Savings Inc (dba) Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Contact | Brandi J. Panteleon |
| Correspondent | Brandi J. Panteleon Surgical Instrument Service And Savings Inc (dba) Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-05 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888277376359 | K171324 | 000 |
| 10888277383838 | K171324 | 000 |
| 10888277383562 | K171324 | 000 |
| 10888277380264 | K171324 | 000 |
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| 10888277378841 | K171324 | 000 |
| 10888277377561 | K171324 | 000 |
| 10888277391529 | K171324 | 000 |
| 10888277390164 | K171324 | 000 |
| 10888277386723 | K171324 | 000 |
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| 10888277386396 | K171324 | 000 |
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| 10888277384408 | K171324 | 000 |
| 10888277379206 | K171324 | 000 |
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| 10888277384682 | K171324 | 000 |
| 10888277387607 | K171324 | 000 |
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| 10888277681460 | K171324 | 000 |
| 10888277669901 | K171324 | 000 |
| 10888277669895 | K171324 | 000 |
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| 10888277669840 | K171324 | 000 |
| 10888277389700 | K171324 | 000 |
| 10888277387744 | K171324 | 000 |
| 10080196385331 | K171324 | 000 |