The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Stryker Neptune 2 Manifolds.
| Device ID | K161358 |
| 510k Number | K161358 |
| Device Name: | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | SURGICAL INSTRUMENT SERVICE AND SAVINGS INC 2747 SW 6TH ST. Redmond, OR 97756 |
| Contact | Brandi J. Panteleon |
| Correspondent | Brandi J. Panteleon SURGICAL INSTRUMENT SERVICE AND SAVINGS INC 2747 SW 6TH ST. Redmond, OR 97756 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2017-08-03 |
| Summary: | summary |