The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Silicone Elastomer Coated Latex Foley.
| Device ID | K810630 |
| 510k Number | K810630 |
| Device Name: | SILICONE ELASTOMER COATED LATEX FOLEY |
| Classification | Catheter, Urological |
| Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-09 |
| Decision Date | 1981-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521017174 | K810630 | 000 |
| 20884521017044 | K810630 | 000 |
| 10884521017054 | K810630 | 000 |
| 20884521017068 | K810630 | 000 |
| 10884521017078 | K810630 | 000 |
| 10884521017085 | K810630 | 000 |
| 10884521017092 | K810630 | 000 |
| 20884521017105 | K810630 | 000 |
| 10884521017115 | K810630 | 000 |
| 10884521017122 | K810630 | 000 |
| 10884521017139 | K810630 | 000 |
| 10884521017146 | K810630 | 000 |
| 10884521016989 | K810630 | 000 |