The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Tandemrx.
| Device ID | K970054 |
| 510k Number | K970054 |
| Device Name: | TANDEMRX |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Lisa M Quaglia |
| Correspondent | Lisa M Quaglia BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-07 |
| Decision Date | 1997-02-10 |
| Summary: | summary |