The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for High Pressure, 1 & 3 Way Sterile Dispos.
| Device ID | K842829 |
| 510k Number | K842829 |
| Device Name: | HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. MEDICAL PRODUCTS DIV Hudson Falls , NY 12839 - |
| Contact | Phillip H Morse |
| Correspondent | Phillip H Morse NORTH AMERICAN INSTRUMENT CORP. MEDICAL PRODUCTS DIV Hudson Falls , NY 12839 - |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965640000011 | K842829 | 000 |
| 20193489065685 | K842829 | 000 |
| 20193489065692 | K842829 | 000 |
| 20193489065708 | K842829 | 000 |
| 20193489058816 | K842829 | 000 |
| 10193489066647 | K842829 | 000 |
| 10193489066654 | K842829 | 000 |
| 10193489066661 | K842829 | 000 |
| 10193489066678 | K842829 | 000 |
| 10193489067163 | K842829 | 000 |
| 10193489077827 | K842829 | 000 |
| 10193489077834 | K842829 | 000 |
| H965808000030 | K842829 | 000 |
| 20193489065678 | K842829 | 000 |