The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for Hh Subcutaneous Access Port.
| Device ID | K833672 |
| 510k Number | K833672 |
| Device Name: | HH SUBCUTANEOUS ACCESS PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Applicant | HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-18 |
| Decision Date | 1984-03-06 |