The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Intherm Single-stick Radially Expanding Dilator.
| Device ID | K931278 |
| 510k Number | K931278 |
| Device Name: | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTERVENTIONAL THERAPEUTICS CORP. 2665 MARINE WAY Mountain View, CA 94043 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols INTERVENTIONAL THERAPEUTICS CORP. 2665 MARINE WAY Mountain View, CA 94043 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1993-07-23 |