The following data is part of a premarket notification filed by Kmb Medical Products Co. with the FDA for Keith Nasogastric Sump Tube W/anti-reflux Valve.
| Device ID | K880850 |
| 510k Number | K880850 |
| Device Name: | KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Applicant | KMB MEDICAL PRODUCTS CO. 320 BROOKES DRIVE, STE. 110 Hazelwood, MO 63042 |
| Contact | C. W Keith |
| Correspondent | C. W Keith KMB MEDICAL PRODUCTS CO. 320 BROOKES DRIVE, STE. 110 Hazelwood, MO 63042 |
| Product Code | FEG |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521141308 | K880850 | 000 |
| 10884521004658 | K880850 | 000 |