The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard(r) Jejunal Feeding/gastric Decompression Tubes.
Device ID | K946249 |
510k Number | K946249 |
Device Name: | BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
Contact | John A Delucia |
Correspondent | John A Delucia C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-23 |
Decision Date | 1995-12-11 |