The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Rf Parallel Bipolar Adaptor Cable.
| Device ID | K061660 |
| 510k Number | K061660 |
| Device Name: | STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jennifer Hoffman |
| Correspondent | Jennifer Hoffman STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2006-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154498611 | K061660 | 000 |