The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Rapidfire Multiple Band Ligator.
Device ID | K971137 |
510k Number | K971137 |
Device Name: | BARD RAPIDFIRE MULTIPLE BAND LIGATOR |
Classification | Ligator, Esophageal |
Applicant | C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
Contact | Beth A Rochette |
Correspondent | Beth A Rochette C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
Product Code | MND |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-28 |
Decision Date | 1997-10-16 |
Summary: | summary |