The following data is part of a premarket notification filed by Intek Int'l, Inc. with the FDA for Air Fluid Exchange Pump.
| Device ID | K832761 |
| 510k Number | K832761 |
| Device Name: | AIR FLUID EXCHANGE PUMP |
| Classification | Syringe, Piston |
| Applicant | INTEK INT'L, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-19 |
| Decision Date | 1983-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853480006006 | K832761 | 000 |