The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Adb Angiographic Dump Bag.
| Device ID | K843726 |
| 510k Number | K843726 |
| Device Name: | NAMIC ADB ANGIOGRAPHIC DUMP BAG |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1984-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965905000401 | K843726 | 000 |
| 20193489068235 | K843726 | 000 |
| 20193489068105 | K843726 | 000 |
| 20193489068112 | K843726 | 000 |
| 20193489068129 | K843726 | 000 |
| 20193489140184 | K843726 | 000 |
| 30193489140198 | K843726 | 000 |
| H965905000181 | K843726 | 000 |
| H965905000281 | K843726 | 000 |
| 20197344066060 | K843726 | 000 |