The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Alimentation Catheters.
| Device ID | K821012 |
| 510k Number | K821012 |
| Device Name: | H-H ALIMENTATION CATHETERS |
| Classification | Catheter, Subclavian |
| Applicant | HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-12 |
| Decision Date | 1982-05-28 |