The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Angiographic Syringe.
| Device ID | K873955 |
| 510k Number | K873955 |
| Device Name: | NAMIC ANGIOGRAPHIC SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Eamonn P Hobbs |
| Correspondent | Eamonn P Hobbs NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-28 |
| Decision Date | 1988-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H749700270901 | K873955 | 000 |
| 20193489066019 | K873955 | 000 |
| 30193489066009 | K873955 | 000 |
| 30193489065996 | K873955 | 000 |
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| 10193489067064 | K873955 | 000 |
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| 10193489066869 | K873955 | 000 |
| 10193489066852 | K873955 | 000 |
| 10193489066845 | K873955 | 000 |
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| 10193489066821 | K873955 | 000 |
| 20193489066095 | K873955 | 000 |
| 30193489065835 | K873955 | 000 |