The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Balloon Dilation Kit With Trifunnel Gastrostomy Tube.
Device ID | K063118 |
510k Number | K063118 |
Device Name: | BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
Contact | Susan Scott |
Correspondent | Susan Scott C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-11 |
Decision Date | 2007-02-13 |
Summary: | summary |