The following data is part of a premarket notification filed by Bard Medical Div. with the FDA for Bardex Lubri-sil I.c. Foley Catheter.
| Device ID | K984136 |
| 510k Number | K984136 |
| Device Name: | BARDEX LUBRI-SIL I.C. FOLEY CATHETER |
| Classification | Catheter, Urological (antimicrobial) And Accessories |
| 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 | MJC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1999-02-16 |
| Summary: | summary |