The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Davol Nasogastric Sump Tube W/prevent Filter.
Device ID | K960176 |
510k Number | K960176 |
Device Name: | DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER |
Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Canston, RI 02920 |
Contact | Robin Drago |
Correspondent | Robin Drago C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Canston, RI 02920 |
Product Code | FEG |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-16 |
Decision Date | 1996-07-24 |
Summary: | summary |