The following data is part of a premarket notification filed by Innerdyne Medical, Inc. with the FDA for Single Stick Radially Expanding Dilator.
| Device ID | K943056 |
| 510k Number | K943056 |
| Device Name: | SINGLE STICK RADIALLY EXPANDING DILATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INNERDYNE MEDICAL, INC. 1244 REAMWOOD AVE. Sunnyvale, CA 94089 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols INNERDYNE MEDICAL, INC. 1244 REAMWOOD AVE. Sunnyvale, CA 94089 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1994-09-27 |