The following data is part of a premarket notification filed by Hdc Corp. with the FDA for J-cath(tm).
| Device ID | K875171 |
| 510k Number | K875171 |
| Device Name: | J-CATH(TM) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
| Contact | Ronald L Coleman |
| Correspondent | Ronald L Coleman HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-04-06 |