The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Biopsy Forceps.
Device ID | K922086 |
510k Number | K922086 |
Device Name: | BARD BIOPSY FORCEPS |
Classification | Esophagoscope, General & Plastic Surgery |
Applicant | C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
Contact | Richard E Franko |
Correspondent | Richard E Franko C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
Product Code | GCL |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-04 |
Decision Date | 1992-10-30 |