The following data is part of a premarket notification filed by Gynecare Innovation Center with the FDA for [specialized Tissue Aspirating Resectoscope (star)].
| Device ID | K962506 |
| 510k Number | K962506 |
| Device Name: | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] |
| Classification | Resectoscope |
| Applicant | GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Product Code | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-27 |
| Decision Date | 1996-09-16 |
| Summary: | summary |