The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Stiegmann-goff Endoscopic Ligator.
Device ID | K940661 |
510k Number | K940661 |
Device Name: | STIEGMANN-GOFF ENDOSCOPIC LIGATOR |
Classification | Ligator, Esophageal |
Applicant | C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
Contact | John Delucia |
Correspondent | John Delucia C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
Product Code | MND |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-15 |
Decision Date | 1994-11-28 |