The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Silastic Brand Foley Catheter.
| Device ID | K951103 |
| 510k Number | K951103 |
| Device Name: | SILASTIC BRAND FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | C.R. BARD, INC. C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30209 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling C.R. BARD, INC. C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30209 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-10 |
| Decision Date | 1995-04-28 |