The following data is part of a premarket notification filed by Bard Medical Div. with the FDA for Bard Flexible Endoscopy Injection System (651019).
| Device ID | K970110 |
| 510k Number | K970110 |
| Device Name: | BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) |
| Classification | Endoscope Channel Accessory |
| Applicant | BARD MEDICAL DIV. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Donna J Wilson |
| Correspondent | Donna J Wilson BARD MEDICAL DIV. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-13 |
| Decision Date | 1997-02-19 |
| Summary: | summary |